MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. REVOLVE; 5.5MM REVOLVE POLYAXIAL PEDICLE SCREW, 50MM

Model Number	185.456
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the device nor any imaging was available for evaluation.A review of the device history record shows no deviations in processing.The exact cause of the reported issue has not yet been determined.
Event or Problem Description
It was reported by a representative from (b)(6) that a revision surgery was completed to remove two broken revolve screws and additional hardware.
Event or Problem Description
It was reported by a representative from spain that a revision surgery was completed to remove two broken revolve screws and additional hardware.
Additional Manufacturer Narrative
Neither the device nor any imaging was available for evaluation.A review of the device history record shows no deviations in processing.The exact cause of the reported issue could not be determined.

• Brand Name: REVOLVE
• Common Device Name: 5.5MM REVOLVE POLYAXIAL PEDICLE SCREW, 50MM
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• MDR Report Key: 12262767
• Report Number: 3004142400-2021-00149
• Device Sequence Number: 2806500
• Product Code: MNH
• UDI-Device Identifier: 00849044070903
• UDI-Public: 00849044070903
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K083416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• 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): 09/01/2021

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: 185.456
• Device Lot Number: BAS173DE
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/20/2021
• Supplement Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 08/02/2021
• Supplement Report FDA Received Date: 09/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other