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

Model Number	185.465
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/19/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the screw head broke off the screw shank post-operatively requiring revision surgery.
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.Evaluation of the returned device found damage to the spherical head of the screw shank and clamps inside the screw head.This observed damage is most likely due to the forceful separation of the components.There are no signs of any manufacturing defects, unusual abrasions, or other observable issues that would lead to the screw head separating from the shank.No determinations can be made as to the cause of the reported issue.The following sections have been updated: b4, e1, e3, h2, h6, h10.

• Brand Name: REVOLVE
• Common Device Name: 6.5MM REVOLVE POLYAXIAL PEDICLE SCREW
• 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: 18837712
• Report Number: 3004142400-2019-00026
• Device Sequence Number: 15257636
• 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: 2019
• Device Explanted Year: 2019
• 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): 03/04/2024

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/21/2019
• Initial Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (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 Age: 79 YR
• Patient Sex: Male
• Patient Weight: 88 KG
• Patient Race: White