MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO MIS STABILIZATION SYSTEM; LOCKING CAP DRIVER

Model Number	6134.0185
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.Neither the device or any imaging could be provided for evaluation.The failure reported is consistent with excessive forces; however, no determinations could be made as to the cause of the reported issue.
Event or Problem Description
It was reported that during surgery the tip of the creo mis locking cap driver was broken and left in the patient.This event occurred in australia.
Event or Problem Description
It was reported that during surgery the tip of the creo mis locking cap driver was broken and left in the patient.This event occurred in australia.
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.Neither the device or any imaging could be provided for evaluation.The failure reported is consistent with excessive forces; however, no determinations could be made as to the cause of the reported issue.The following sections have been updated.B4, e1, h2, h6, h10.B4, e1, g6, h2, h10.

• Brand Name: CREO MIS STABILIZATION SYSTEM
• Common Device Name: LOCKING CAP DRIVER
• 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: 18834287
• Report Number: 3004142400-2023-00074
• Device Sequence Number: 15313292
• Product Code: LXH
• UDI-Device Identifier: 00889095178289
• UDI-Public: 00889095178289
• 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: 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): 08/26/2024

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
• Device Model Number: 6134.0185
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2023
• Supplement Date Received by Manufacturer: 03/28/2023
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown