MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; THREADED LOCKING CAP DRIVER

Model Number	6120.5000
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the device nor any imaging was available for evaluation.No determinations could be made as to the cause of the reported issue.
Event or Problem Description
It was reported that the tip of the driver broke off during provisional tightening, and remains in the patient.

• Brand Name: CREO
• Common Device Name: THREADED LOCKING CAP DRIVER
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• MDR Report Key: 11802232
• Report Number: 3004142400-2021-00087
• Device Sequence Number: 1099383
• Product Code: LXH
• UDI-Device Identifier: 00889095173604
• UDI-Public: 00889095173604
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K124058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 6120.5000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 05/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 74 YR