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

Model Number	1134.0010
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was available for evaluation.It was reported that a revision was needed to replace creo mis locking cap that was found migrated post operatively with subsequent loosened set screws.The original surgery was completed in (b)(6) 2024 for t5-t11 posterior fusion via a trauma accident.It was stated there were multiple co-morbidities due to multiple trauma surgeries.It is unclear if these co-morbidities contributed to the implant migration.The x-ray images provided confirmed that the t11 set screws on the left side migrated post-operatively.Six locking caps were returned along with three assembled mis screws.Visual inspection of the locking caps do not show signs of major deformation or damage.The underside of the locking cap has the traditional hourglass wear pattern which confirms the locking cap engaged the rod.It is possible that there was excessive in-situ forces on the construct due to the multiple co-morbidities that caused the locking cap to migrate.The observed overall risk level is low, which matches the observed anticipated risk level; therefore, the overall risk of the system has been maintained.However, because these forces and surgical conditions cannot be replicated, no determinations could be made as to the cause of the reported issue.
Event or Problem Description
It was reported that a revision was needed to replace creo mis locking cap that was found migrated post operatively with subsequent loosened set screws.

• Brand Name: CREO
• 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: 20239561
• Report Number: 3004142400-2024-00204
• Device Sequence Number: 12928491
• 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 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): 09/17/2024

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: BAB8A9MC/BAB778FC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/20/2024
• Initial Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/02/2023
• 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: 33 YR
• Patient Sex: Female