MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. RESONATE; RESONATE ANTERIOR CERVICAL PLATE, EXTRA LORDOTIC, 3-LEVEL, 54MM

Model Number 1194.3154

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 07/07/2023

Event Type  malfunction  

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.The device was returned for evaluation.Initial observation shows one broken slider and one broken screw.The imaging providd showed one back out screw and one broken screw, both at the bottom level.No determinations could be made as to the cause of the reported issue.The following sections have been updated: b4, e1, h2, h6, h10.

Event Description

It was reported that a revision surgery was needed to replace a screw that backed out of a resonate plate post-operatively with subsequent screw breakage.

• Brand Name: RESONATE
• Type of Device: RESONATE ANTERIOR CERVICAL PLATE, EXTRA LORDOTIC, 3-LEVEL, 54MM
• 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: 18837525
• MDR Text Key: 337156302
• Report Number: 3004142400-2023-00109
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 00193982155551
• UDI-Public: 00193982155551
• 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: 03/04/2024

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: 1194.3154
• Device Lot Number: ETX330AA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2023
• Date Manufacturer Received: 07/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2020
• 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