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	06/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a revision surgery was needed to replace creo mis locking caps that migrated post operatively with subsequent rod slippage.
Additional Manufacturer Narrative
The device was available for evaluation.It was reported that a creo mis locking cap in the right l5 screw had loosened post-operatively.The initial surgery on (b)(6) 2023 was for an l5-s1 thoracolumbar fusion with a tlif.The patient was instrumented with creo mis.During a revision surgery on (b)(6) 2024, the 45mm mis rod, s1 locking cap, and loose l5 locking cap were removed from the patient.Visual inspection of one of the locking caps found significant wear on the bottom surface of the locking cap around the outer edge, consistent with final tightening.Minimal wear was found on the bottom of the second locking cap with slight deformation concentrated to one side of the bottom surface.The deformation is consistent with imbalanced pressure applied to the locking cap.This could have occurred if there was interference between the proximal ends of adjacent mis screw heads which prevented the screw head and locking cap from being normalized to the rod.It is possible that final tightening a screw head that was not normal to the rod caused the load to be distributed unevenly across the bottom of the locking cap, consistent with the observed deformation.Visual inspection of the rod found wear on the top surface in two separate locations, with one location showing more severe wear than the other location.The location of greater wear suggested the locking cap may have been positioned over the attachment feature.If this created inadequate contact between the locking cap and rod, it is possible the integrity of the construct was compromised.Because surgical conditions could not be replicated, the exact cause of the reported issue could not be determined.

• 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: 19843732
• Report Number: 3004142400-2024-00156
• Device Sequence Number: 7815721
• 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: 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: 1134.0010
• Device Lot Number: BAA833MC/BAB778CC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/28/2024
• Initial Report FDA Received Date: 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2022
• 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: 70 YR
• Patient Sex: Male