MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; DRIVER SHAFT, 1/4" QUICK-CONNECT, SHORT

Model Number	6067.0050
Health Effect - Clinical Codes	Pain (1994); Device Embedded In Tissue or Plaque (3165)
Date of Event	03/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the part nor any imaging was available regarding the spacer.Additional information provided that the tip of the driver fractured during an attempt to remove the locking cap, meaning that the tip yielded and fractured in a counter-clockwise direction.This is consistent with the driver being subject to excessive force; however, the exact cause of the reported issue could not be determined.
Event or Problem Description
It was reported by a representative from japan that a revision surgery was done to remove a spacer due to patient pain.During the surgery, the driver tip broke and remains in the patient.
Event or Problem Description
It was reported by a representative from japan that a revision surgery was done to remove a spacer due to patient pain.During the surgery, the driver tip broke and remains in the patient.
Additional Manufacturer Narrative
Neither the part nor any imaging was available regarding the spacer.Additional information provided that the tip of the driver fractured during an attempt to remove the locking cap, meaning that the tip yielded and fractured in a counter-clockwise direction.This is consistent with the driver being subject to excessive force; however, the exact cause of the reported issue could not be determined.

• Brand Name: CREO
• Common Device Name: DRIVER SHAFT, 1/4" QUICK-CONNECT, SHORT
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• MDR Report Key: 11689131
• Report Number: 3004142400-2021-00070
• Device Sequence Number: 19726772
• Product Code: LXH
• UDI-Device Identifier: 00889095167948
• UDI-Public: 00889095167948
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: D154976
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 6067.0050
• Device Lot Number: ADV052AD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2021
• Initial Date Received by Manufacturer: 03/22/2021
• Supplement Date Received by Manufacturer: 03/22/2021
• Initial Report FDA Received Date: 04/19/2021
• Supplement Report FDA Received Date: 05/26/2021
• 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: 78 YR