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	Insufficient Information (4580)
Date of Event	06/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was unavailable for evaluation.It was reported that a revision surgery was needed to replace creo locking caps that migrated post operatively.The patient is a larger 60-year-old white male with an original construct of l5-s1 tlif on (b)(6) 2024.The revision surgery extended the construct from l2 to the pelvis on (b)(6) 2024.No new interbody implant was used.No determinations 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 locking caps that migrated post operatively.

• 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: 19843770
• Report Number: 3004142400-2024-00157
• Device Sequence Number: 20482439
• 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): 07/26/2024

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
• Operator of Device: Health Professional
• Device Model Number: 1119.0010
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 59 YR
• Patient Sex: Male
• Patient Race: White