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

Model Number 597.616

Device Problems Break (1069); Material Protrusion/Extrusion (2979)

Patient Problem Insufficient Information (4580)

Event Date 09/15/2021

Event Type  malfunction  

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 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
• Type of Device: UNIFY 4.2MM VARIABLE ANGLE SCREW, SELF-DRILLING, 16MM
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• Manufacturer (Section G): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• Manufacturer Contact: daniel paul ; 2560 general armistead avenue; audubon 19403 ; 6109301800
• MDR Report Key: 12600909
• MDR Text Key: 277103826
• Report Number: 3004142400-2021-00196
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 00889095166743
• UDI-Public: 00889095166743
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: D235765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 597.616
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/24/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other