MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. ASSURE® - ANTERIOR CERVICAL PLATE SYSTEM; ASSURE CERVICAL PLATE 3-LEVEL, 54MM

Model Number 110.354

Device Problem Material Fragmentation (1261)

Patient Problem Insufficient Information (4580)

Event Date 06/19/2023

Event Type  malfunction  

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.The device was returned for evaluation.The fragment was lost during the washing process and could not be retrieved.No determinations could be made as to the cause of the reported issue.

Event Description

It was reported that during a surgery the patient was found bleeding from a metal shaving found on top of the assure cervical plate. .

• Brand Name: ASSURE® - ANTERIOR CERVICAL PLATE SYSTEM
• Type of Device: ASSURE CERVICAL PLATE 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: 18837657
• MDR Text Key: 337212822
• Report Number: 3004142400-2023-00100
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 00849044093124
• UDI-Public: 00849044093124
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040721
• 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: 110.354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2023
• Date Manufacturer Received: 06/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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