Globus Medical Faces FDA Ire in New Warning Letter

FDA today published a warning letter to Globus Medical after finding alleged violations at its facility in Audobon, PA. The letter, dated July 15, refers to an inspection which took place from Feb. 14 through March 7 of this year.

Centering on the company’s Excelsius CPS surgical robot and associated interbody spine and cranial modules, the agency said that the inspection revealed the devices had been adulterated or were not in conformity with current good manufacturing practice requirements.

Violations

The warning letter detailed violations including a failure to establish and maintain procedures for implementing corrective and preventative actions like, “requirements for analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems using appropriate statistical methodology,” according to FDA.

Giving an example of misplaced screws, the agency that Globus did not initiate CAPAs despite documentation of complaints. Globus provided data showing counts of misplaced screws per 10,000 implanted from 2017 to 2024. FDA, however, alleges the company used no additional level of data analyses to understand potential trends or identify appropriate statistical methods to detect ongoing issues.

“… There was no additional level of data analyses, using appropriate statistical methodology, to determine whether there are any trends associated with part numbers, including the spine and cranial modules; lot numbers; patient symptoms; confirmed and alleged defects; causes determined by complaint investigations (eg, software, components, user error); etc. for complaints specifically related to misplaced screws navigated by the EGPS surgical robot,” according to the warning letter. “Therefore, the overarching concern is that the trend analysis you rely on to determine whether CAPAs should be initiated does not employ appropriate statistical methodology to detect recurring quality problems. Furthermore, there was no information provided on how your firm evaluated risk as a factor in determining whether to initiate a CAPA for this issue.”

Another violation was the company’s failure to review, evaluate, and investigate complaints involving the possible failure of a device to meet any of its specifications. Specifically, FDA highlighted an instance that Globus did not follow product complaint procedures which require comprehensive complaint investigations. The procedure, according to the agency, did not even include details on what constitutes a comprehensive investigation.

“For example, your complaint record lacked details on how you concluded that there was no device malfunction or user error for complaint COM-21-3115 (10/5/21) where the EGPS surgical robot was in use when a patient experienced adverse health effects and passed away,” the letter wrote. “In addition, the complaint record for COM-22-0414 (2/10/22), received for ‘screw missed pedicle which then went superior into the disc space and the screw was removed,’ lacked evidence that you made multiple attempts to verify whether a malfunction occurred.”

MDR violations

The warning letter also went on to allege issues with Medical Device Reporting (MDR) at the facility. The inspection found that the Excelsius GPS devices were allegedly misbranded, “in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 – Medical Device Reporting,” according to FDA.

Significant violations to MDR included a failure to submit a report to FDA no later than 30 calendar days after the day the company received or became aware of information that reasonably suggests a company product may have caused or contributed to a death of serious injury.

As evidence of this violation, FDA found that Globus had failed to submit a report within the 30 days to FDA after receiving a complaint in which a patient had damage to the dural lining of the spinal cord during a procedure using the EGPS spinal robotic system. The issue resulted in additional surgical intervention and repair.

“There is no information reasonably suggesting that the device might not be a contributing factor to the patient’s serious injury,” according to the warning letter. “As such, the referenced event meets the criteria for an MDR reportable serious injury.”

Globus became aware of the event on Sept. 24, 2019. A malfunction MDR about the event was received by FDA on March 12, 2024.

Additionally, the agency also said the inspection uncovered a failure to maintain copies of electronic acknowledgements sent by FDA in response to electronic MDR submissions.

An 8% dip

After the report was published, Globus saw its stock price fall more than 8% to $66.83 per share in midday trading, which BTIG analysts Ryan Zimmerman and Iseult McMahon said is an overreaction based on multiple factors. The company, which is number two in the spinal implant market, has not been told to halt the sale of its Excelsius GPS, and has enough of a market presence outside of robotics that “share shifts of greater magnitude within spinal hardware are unlikely,” according to the analysts.

“While the Letter outlines a number of issues which GMED will have to resolve, we think the move in shares is overdone,” the analysts said. “GMED's Emerging Technology business comprised almost entirely of ExcelsiusGPS sales was ~8% in FY23 and we expect it to be ~6% in FY24. Presently GMED shares are down ~8% shedding ~$1B in market value for a business that does ~$120M - $140M in sales growing in the high-teens.”