MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. REVERE; 5.5MM REVERE PEDICLE SCREW, 40MM

Model Number	124.454
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not available for evaluation.There were two images provided showing the main body attached to the rod and the screw shank disassembled from the main body.One clamp was disassembled from the main body and the second half of the clamp remained in the main body.From the provided images, the screw head appears to have some damage from excessive force, causing the disassembly to occur, but this cannot be confirmed.No determinations could be made as to the cause of the reported issue.
Event or Problem Description
It was reported that a revision was performed to remove and replace a revere screw head that had separated from the shank 5 days post operatively.This event occurred in austria.

• Brand Name: REVERE
• Common Device Name: 5.5MM REVERE PEDICLE SCREW, 40MM
• 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: 20079270
• Report Number: 3004142400-2024-00190
• Device Sequence Number: 15353067
• Product Code: MNH
• UDI-Device Identifier: 00849044001167
• UDI-Public: 00849044001167
• 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
• Report Date (Section B): 08/27/2024

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: 124.454
• Device Lot Number: BAB8CFWV
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/05/2024
• Initial Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2023
• 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 Sex: Female