MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO MIS 5.5MM CURVED ROD, TITANIUM ALLOY, 95MM LENGTH

Model Number	1134.7095
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	01/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The implant has not been returned at this time for evaluation.The cause of the reported issue cannot be traced at this time.
Event or Problem Description
It was reported that a revision surgery was needed to replace a creo rod that fractured and migrated out of the patient's skin with subsequent loose locking caps 3 years post operatively.
Event or Problem Description
It was reported that a revision surgery was needed to replace a creo rod that fractured and migrated out of the patient's skin with subsequent loose locking caps 3 years post operatively.
Additional Manufacturer Narrative
The device was available for evaluation.It was reported that the patient was implanted in (b)(6) 2023 from t9-pelvis.Images show a rod fractured between l4 and l5 on the left, and a rod fractured between s1 and s2ai on the right, along with migrated locking caps.The fractured piece on one side had migrated outside the patient's skin and was not available to be returned for evaluation.This rod was not seen to have been fractured from its separate image submitted.It was reported that the patient was seen by the doctor 3 months post-op, and had not been available for follow-up 6 months post-op.The was patient was reported to have healed from the protruding migrated rod without infection.Other implants from the same construct that were removed in the revision surgery after the described event were returned and evaluated.No determinations could be made as to the cause of the reported issue.The following sections been updated: b4; d4; d9; g6; h3; h4; h6; h10.

• Brand Name: CREO
• Common Device Name: CREO MIS 5.5MM CURVED ROD, TITANIUM ALLOY, 95MM LENGTH
• 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: 21482537
• Report Number: 3004142400-2025-00034
• Device Sequence Number: 8414223
• Product Code: MNH
• UDI-Device Identifier: 00889095072273
• UDI-Public: 00889095072273
• 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: 2022
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2025

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: 1134.7095
• Device Lot Number: JN1425MC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2025
• Supplement Date Received by Manufacturer: 01/31/2025
• Initial Report FDA Received Date: 02/27/2025
• Supplement Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2025
• 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: 73 YR
• Patient Sex: Male
• Patient Race: White