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	02/18/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that two revolve screws broke at the shaft.
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.The two screws were returned with a fracture approximately half of the screw length from the screw head.Only the proximal end of the screws were returned.The screws were inspected and all relevant dimensions of the screw assembly were measured.The dimensions were determined to be within specification.There are no signs of manufacturing defects or wear marks that could be attributed to the fracture.Analysis of the break surface is indicative of bending fatigue, which could be caused by excessive bending moments; however, it is not possible to determine the exact cause of the break.The following sections have been updated: b4, e1, e3, h2, h6, h10.

• 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: 18816286
• Report Number: 3004142400-2018-00017
• Device Sequence Number: 12804333
• 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: K083416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• 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): 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 185.465
• Device Lot Number: BAT417EE, BAS071XE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/22/2018
• Initial Report FDA Received Date: 03/01/2024
• 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: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Hispanic
• Patient Race: White