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

Model Number	1134.0010
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	07/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a revision was needed to replace a creo mis locking head that was found loose post operatively.This event occurred in japan.
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.The device was returned for evaluation.One of the locking caps showed minimal wear on the bottom of the cap on one side and the top of the threads.Because the wear was seen only on one edge, it possible that the cap wasn't completely normal to the rod.The other had no visible wear.When creo mis locking caps are final tightened, it is typical to see an hour-glass wear pattern on the bottom.This pattern was not present on the returned caps.It is not known which locking cap was placed in l5 and migrated.No determinations could be made as to the cause of the reported issue.The following sections are been updated: b4, e1, h2, h6, h10.

• 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: 18837913
• Report Number: 3004142400-2023-00132
• Device Sequence Number: 15277291
• 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: 2023
• Device Explanted Year: 2023
• 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): 02/29/2024

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: BAB004NC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/09/2023
• Initial Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2023
• 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: 72 YR
• Patient Sex: Male
• Patient Race: Asian