Dive Brief:
- Globus Medical received a Food and Drug Administration warning letter after inspectors found quality system violations at a plant that makes a surgical robot.
- The FDA, which published the letter on Tuesday, said the musculoskeletal device company failed to investigate complaints of misplaced screws implanted during surgeries and meet the requirements for reporting serious injuries. The warning letter was dated July 15.
- RBC Capital Markets analysts said in a note to investors the risks around the warning letter are manageable because the FDA has not flagged product safety concerns and no devices are being recalled.
Dive Insight:
The FDA inspected a Globus facility that makes the Excelsius GPS (EGPS) surgical robot in February and March. The inspectors found fault with Globus’ compliance with the quality system regulation and the medical device reporting requirements.
Globus failed to start corrective and preventative action procedure investigations in response to complaints about misplaced screws, according to the FDA. Globus gave the agency data on the rate of the issue for screws implanted from 2017 and 2024. However, the FDA said the response was inadequate because it lacked analyses to determine if there were trends linked to part numbers.
The agency also made observations about the comprehensiveness of Globus’ investigations. In one case, the company’s documents lacked details of how it concluded there was no device malfunction when a patient died during a procedure involving the EGPS.
The FDA’s concerns about medical device reporting relate to the timing of submissions. Globus filed a report about damage to the dural lining of a patient's spinal cord in March 2024, days after the FDA concluded its inspection. The company learned of the injury in September 2019.
Information in another set of complaints “reasonably suggests that your firm’s EGPS spinal robotic system malfunctioned (i.e., misplaced screws) while in use,” the FDA said. The agency said it believes the “referenced malfunction would be likely to cause or contribute to a death or serious injury if it were to recur.”
Analysts at BTIG, RBC and Truist Securities published notes about the warning letter. None of the analysts expect the FDA action to have a significant effect on Globus’ financials. Truist analysts said that the letter looks “like more ‘bark than bite’” at first glance, noting that the “observations appear to us less complex to manage/resolve than product related deficiencies.”
BTIG analysts expect Globus to keep market share.
“While investors may worry that competitors could use this to counter-detail against [Globus], specifically within spinal robotics, we think [Globus] business, outside of robotics has enough of a market presence (#2 in the spinal implant market) that share shifts of greater magnitude within spinal hardware are unlikely,” the analysts wrote.
RBC analysts said Globus has provided its response to the FDA warning letter. Complying with the FDA’s reporting standards will not require “spending meaningfully,” the analysts said, because the fixes should be “fairly straightforward.”
