MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. REVERE STABILIZATION SYSTEM; REVERE 5.5 THREADED LOCKING CAP

Model Number	524.100
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a revision was needed to remove revere locking caps that were found to be loose.This event occurred in sweden.
Additional Manufacturer Narrative
The device was not available for evaluation.No determinations could be made as to the cause of the reported issue.
Additional Manufacturer Narrative
The device was not available for evaluation.It was reported that revision surgery is required due to the loosening of revere locking caps.The image provided shows a 1-level construct with the two caps on the right side of the construct no longer engaged with the screw head.It was stated that the patient did not fuse.No determinations could be made as to the cause of the reported issue.The following sections have been updated for this supplemental report:.
Event or Problem Description
It was reported that a revision was needed to remove revere locking caps that were found to be loose.This event occurred in sweden.

• Brand Name: REVERE STABILIZATION SYSTEM
• Common Device Name: REVERE 5.5 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: 22013633
• Report Number: 3004142400-2025-00104
• Device Sequence Number: 7984970
• Product Code: MNH
• UDI-Device Identifier: 00889095160246
• UDI-Public: 00889095160246
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K133350
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 06/12/2025

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: 524.100
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/28/2025
• Supplement Date Received by Manufacturer: 04/28/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: White