MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. RESONATE; RESONATE ANTERIOR CERVICAL PLATE, 1-LEVEL, 14MM

Model Number 1194.1014

Device Problem Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

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

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.The device was not available for evaluation as it remains in the patient.The imaging provided shows something protruding from the plate slightly at the bottom level.The follow-up image shows the head of the screw at that level is protruding from the plate.It is unclear whether the cause was a damaged slider or if the screw was not fully seated in the plate.No determinations could be made as to the cause of the reported issue.

• Brand Name: RESONATE
• Type of Device: RESONATE ANTERIOR CERVICAL PLATE, 1-LEVEL, 14MM
• 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: 18837895
• MDR Text Key: 336904253
• Report Number: 3004142400-2023-00134
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 00193982154271
• UDI-Public: 00193982154271
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192314
• 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: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1194.1014
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Race: Black Or African American