MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. UNIFY; TEMPORARY PLATE SPACER, 3MM

Model Number	697.003
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not availble for evaluation as it remains in the patient.It was reported and confirmed that stainless steel radio-opaque marker on the posterior side of the temporary plate spacer disassembled intra-operatively; the small metal part on the back of the temporary plate spacer fell down from 3 spaces.No determinations can be made as to the cause of the reported issue.
Event or Problem Description
It was reported that during a case a piece of a unify temporary plate spacer broke and remains in the patient post operatively.This event occurred in hungary.

• Brand Name: UNIFY
• Common Device Name: TEMPORARY PLATE SPACER, 3MM
• 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: 19483716
• Report Number: 3004142400-2024-00123
• Device Sequence Number: 15481159
• Product Code: KWQ
• UDI-Device Identifier: 00889095058581
• UDI-Public: 00889095058581
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K121049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 06/05/2024

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: 697.003
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/16/2024
• Initial Report FDA Received Date: 06/07/2024
• 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