MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. RESONATE; RESONATE ANTERIOR CERVICAL PLATE, 2-LEVEL, 34MM

Model Number 1194.3045

Device Problem Device Slipped (1584)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

The device was not available as it remains in the patient.Imaging provided showed the screw to have backed out past the blocking mechanism at the superior level of a 2 level plate.No determinations can be made as to the cause of the reported issue.There are no plans for a revision surgery.

Event Description

It was reported that a resonate screw is backing out of a plate post-operatively.

• Brand Name: RESONATE
• Type of Device: RESONATE ANTERIOR CERVICAL PLATE, 2-LEVEL, 34MM
• 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: 12242230
• MDR Text Key: 265991504
• Report Number: 3004142400-2021-00128
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 00193982155360
• UDI-Public: 00193982155360
• 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: 07/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1194.3045
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/01/2021
• 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