MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. UNIFY; UNIFY 4.2MM VARIABLE ANGLE SCREW, SELF-DRILLING, 16MM

Model Number	597.616
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The devices were not available for evaluation as they remain in the patient.The images provided showed that the first and last screw in a four screws construct had broken during insertion of a plate located at c7-t1, both screws were located at t1.It appears that the four tabs on the screw snapped off.The plate is supported by an ellipse construct at c5-t2.The patient is not experiencing any pain and is staying under close watch.No revision surgery is planned at the moment.An exact cause of the reported issue cannot be determined at this time.
Event or Problem Description
It was reported that two unify screws broke during insertion and was left slightly protruding from the plate.This event occurred in (b)(6).

• Brand Name: UNIFY
• Common Device Name: UNIFY 4.2MM VARIABLE ANGLE SCREW, SELF-DRILLING, 16MM
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• MDR Report Key: 12600909
• Report Number: 3004142400-2021-00196
• Device Sequence Number: 19140489
• Product Code: KWQ
• UDI-Device Identifier: 00889095166743
• UDI-Public: 00889095166743
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: D235765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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
• Report Date (Section B): 10/08/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 597.616
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/24/2021
• Initial Report FDA Received Date: 10/08/2021
• 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