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

Model Number	1134.0010
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/24/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported by globus medical japan, that six locking caps loosened post-operatively.

• Brand Name: CREO MIS
• Common Device Name: 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
• Report Number: 3004142400-2020-00035
• Device Sequence Number: 7214632
• Product Code: MNH
• UDI-Device Identifier: 00889095071139
• UDI-Public: 00889095071139
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K124058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• 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): 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
• Operator of Device: Health Professional
• Device Model Number: 1134.0010
• Device Lot Number: BAW501FB, BAW517HB
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2020
• Initial Report FDA Received Date: 03/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 80 YR
• Patient Sex: Unknown
• Patient Race: Asian