MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. RESONATE EXTREME ANGLE ANTERIOR CERVICAL PLATE SYSTEM; RESONATE ANTERIOR CERVICAL PLATE, 2-LEVEL, 36MM

Model Number 1194.2036

Device Problem Device Slipped (1584)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

The device was not available for evaluation as it remains in the patient.Imaging provided showed a screw backing out past the blocking mechanism at the inferior level of a 2 level plate that was originally implanted on (b)(6) 2021.The back-out was originally discovered on imaging on (b)(6) 2021.During a routine follow-up.Additional information provided shares that the patient remains well and there is no plan for revision.The surgeon is confident that the screw was fully seated and covered by the locking mechanism.The patient is staying under close watch.An exact cause of the reported issue cannot be determined.

Event Description

It was reported that a resonate plate backed out post operatively.

• Brand Name: RESONATE EXTREME ANGLE ANTERIOR CERVICAL PLATE SYSTEM
• Type of Device: RESONATE ANTERIOR CERVICAL PLATE, 2-LEVEL, 36MM
• 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 ; 6109301822
• MDR Report Key: 12799675
• MDR Text Key: 283518031
• Report Number: 3004142400-2021-00208
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 00193982154875
• UDI-Public: 00193982154875
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: D360198
• 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: 11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1194.2036
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/03/2021
• 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