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

Model Number	1119.0010
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Spinal Cord Injury (2432)
Date of Event	02/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was available for evaluation.It was reported that a revision surgery was needed to replace ten creo threaded locking caps that were found loose post operatively.The initial surgery was an l3-s2ai plif completed on (b)(6) 2024.No issues were reported during the initial surgery.On (b)(6) 2024 a revision surgery was completed for additional decompression.At this time the surgeon found a few of the locking caps were loose and chose to replace all of the locking caps with new ones.No images were available for evaluation.The locking caps were returned and 6 of the 10 locking caps exhibit wear patterns that are consistent with being properly tightened.The other 4 show slight signs of the same wear pattern, however, it is much less apparent.The torque limiting handle used in the surgery was not returned for evaluation.Although 10 caps were returned, no identification was provided that indicated their positioning, therefore, no correlation could be made to associate any individual cap to the issue.Because the surgical and post operative conditions cannot be replicated, images were not provided, and all of the implants and instruments that could create the issue were not returned for evaluation, no determination could be made as to the cause of the reported issue.
Event or Problem Description
It was reported that a revision surgery was needed to replace creo threaded locking caps that were found loose post operatively.This event occurred in japan.

• Brand Name: CREO
• Common Device Name: CREO THREADED 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: 19014539
• Report Number: 3004142400-2024-00060
• Device Sequence Number: 14405257
• Product Code: MNH
• UDI-Device Identifier: 00889095059496
• UDI-Public: 00889095059496
• 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: 2024
• Device Explanted Year: 2024
• 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): 03/20/2024

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: 1119.0010
• Device Lot Number: BAB913DD/BAX747KD/BAY067JD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/04/2024
• Initial Report FDA Received Date: 04/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2023
• 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 Sex: Female
• Patient Race: Asian