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

Model Number	6124.0003
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial observation of the returned device shows the threaded tip of the instrument has fractured off.Additional information provided that the implant started to articulate before it was intended during the impaction insertion.The implant was still able to be placed in position, but upon attempting to expand it was discovered that the inserter had disengaged from the implant due to the fractured tip.Expansion was not able to be achieved.The fractured threaded tip was fully captured by the implant threads and not loose in the disc space.It is possible that the gold knob was loosened or partially loosened, allowing direct loading of the threaded tip and eventual failure during impaction; however, an exact cause of the reported issue could not be established.
Event or Problem Description
The threaded portion of rod sheared off in the implant.The threads were not recoverable, and were left in the implant.

• Brand Name: CREO STABILIZATION SYSTEM
• Common Device Name: DRIVER SHAFT, 1/4" QUICK-CONNECT, SHORT
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer (Section G): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer Contact: daniel paul ; 2560 general armistead avenue; audubon, PA 19403 ; 6109301800
• MDR Report Key: 16468388
• Report Number: 3004142400-2023-00022
• Device Sequence Number: 5263164
• Product Code: LXH
• UDI-Device Identifier: 00889095167948
• UDI-Public: 00889095167948
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: D154976
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/28/2023

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: 6124.0003
• Device Lot Number: FMX021LE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2023
• Initial Report FDA Received Date: 03/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male