FDA Sends Warning Letter To Surgical Robot Maker Globus
August 15th, 2024 // 2:21 pm @ jmpickett
FDA delivered a warning letter to Globus Medical in August 2024 for not following quality system regulations and medical device reporting requirements. The FDA warning letter also stated that the firm’s CAPA procedures were not properly addressed regarding quality problems, including Globus Medical’s analysis of reports of missing surgical screws.
FDA sent the warning letter to Globus Medical on July 15, noting several regulatory issues. FDA inspectors looked into the manufacturer of the Excelsius GPS surgical robot and its related accessories in early 2024 and found there were several problems with cGMPs and MDR handling procedures.
Globus responded to FDA’s concerns in a recent 483. However, FDA said the response was inadequate. The FDA said the company didn’t implement necessary CAPA procedures, particularly related to reports for missing screws.
FDA stated in its 483 response that Globus offered data showing misplaced screw counts per 10,000 screws that were implanted between 2017 and 2024. But, FDA noted, there were no increased levels of data analysis with statistical methodology, to show if there were trends regarding part numbers, lot numbers, patient symptoms, alleged and confirmed defects, causes associated with various complaint investigations, etc.
FDA also said that their main concern is that the firm’s trend analysis for deciding if a CAPA should be started is their procedures fail to use statistical methodology to find recurring quality issues. The company also did not show how it evaluated risk as one factor that determined if they should begin a CAPA.
FDA also stated that Globus didn’t follow QSR regulations because it didn’t evaluate, review, or investigate complaints that its products didn’t meet specifications. FDA also said the firm didn’t file required MDR reports within 30 days of getting an AER related to the use of their products.
