MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. RESONATE; RESONATE ANTERIOR CERVICAL PLATE, 2-LEVEL, 32MM

Model Number 1194.2032

Device Problem Break (1069)

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 immediate post-operative image all screws appear to be fully seated.The follow-up images show the head of a bottom screw is partially 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.The following sections are been updated: b4, e1, h2, h6, h10.

• Brand Name: RESONATE
• Type of Device: RESONATE ANTERIOR CERVICAL PLATE, 2-LEVEL, 32MM
• 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: 18838074
• MDR Text Key: 337155540
• Report Number: 3004142400-2023-00138
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 00193982154837
• UDI-Public: 00193982154837
• 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: 03/01/2024

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: 1194.2032
• 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: 48 YR
• Patient Sex: Female
• Patient Race: Black Or African American