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

Model Number 1134.0010

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 03/24/2020

Event Type  malfunction  

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.Evaluation of the returned locking caps was performed.Wear was observed on the bottom side of the cap where it had contact with the rod.Two of the locking c.Aps had a ring shaped wear pattern which could indicate uneven loading on the cap and that one side of the cap had more contact with the rod than the other.It's possible the locking caps were not sufficiently tightened to the rod due to an obstruction preventing proper seating of the cap, insufficient tightening, or damage to the locking cap or screw head during or prior to surgery.Additionally, it's possible that excessive force placed on the implant during unknown patient loading may have contributed to the observed issue.However, the exact cause of the reported issue cannot be determined.

Event Description

It was reported by globus medical japan, that six locking caps loosened post-operatively.

• Brand Name: CREO MIS
• Type of Device: CREO MIS LOCKING CAP
• 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: 18823392
• MDR Text Key: 336808079
• Report Number: 3004142400-2020-00035
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 00889095071139
• UDI-Public: 00889095071139
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K124058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/02/2024

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 Operator: Health Professional
• Device Model Number: 1134.0010
• Device Lot Number: BAW501FB, BAW517HB
• Initial Date Manufacturer Received: 03/25/2020
• Initial Date FDA Received: 03/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 80 YR
• Patient Race: Asian