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

Model Number	124.000
Medical Device Problem Code	Installation-Related Problem (2965)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The part is not available for evaluation at this time.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 a revere locking cap due to a screw sticking out.This event occurred in germany.
Additional Manufacturer Narrative
The device was available for evaluation.The locking cap was returned with the set screw in the fully loosened position as it is originally supplied per the drawing.Significant torque was required to "break" the set screw free to thread it clockwise indicating excessive torque may have been applied in the counter-clockwise direction.Once the initial torque was overcome, the set screw threaded clockwise with some resistance.Once loosened, it was found that the bottom shoulder of the set screw that retains it into the locking cap body was deformed downward, further indicating that excessive torque was applied in the counter-clockwise direction.This deformation caused the binding of the set screw in the locking cap body.The locking cap body looked to be in good condition showing normal signs of use.This risk is documented and within expected parameters, and will continue to be monitored.No further 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 a revere locking cap due to a screw sticking out.This event occurred in germany.

• Brand Name: REVERE
• Common Device Name: REVERE 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: 21105590
• Report Number: 3004142400-2025-00015
• Device Sequence Number: 12951289
• Product Code: MNH
• UDI-Device Identifier: 00849044000207
• UDI-Public: 00849044000207
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K061202
• 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,Followup
• Report Date (Section B): 02/05/2025

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: 124.000
• Device Lot Number: BGA362AJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/20/2024
• Supplement Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/28/2022
• 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 Sex: Unknown