Globus receives warning letter over spine navigation robot (MedTechDive)
Globus Medical received an FDA warning letter related to its ExcelsiusGPS robotic navigation system for spine surgeries. Retrieved from Globus Medical on August 14, 2024
The FDA said Globus delayed reporting complaints about misplaced screws, despite information that “reasonably suggests” the Excelsius GPS system malfunctioned.
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 Globu...
