MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. REVOLVE; 6.5MM REVOLVE POLYAXIAL PEDICLE SCREW, 45MM

Model Number	185.465
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not available for evaluation.It was reported that a revision surgery was needed to replace a revolve screw broken post operatively.From the x-ray provided both s1 screws were broken halfway down its shank and a revision with creo was performed on (b)(6)2024.Caliber remained and the screws in s1 were changed.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 due to a revolve screw that was found broken post operatively.This event occurred in austria.

• Brand Name: REVOLVE
• Common Device Name: 6.5MM REVOLVE POLYAXIAL PEDICLE SCREW, 45MM
• 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: 19637081
• Report Number: 3004142400-2024-00138
• Device Sequence Number: 8610811
• Product Code: MNH
• UDI-Device Identifier: 00849044070958
• UDI-Public: 00849044070958
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K110280
• 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): 06/28/2024

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: 185.465
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2024
• Initial Report FDA Received Date: 06/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Race: White