MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. ASSURE ANTERIOR CERVICAL PLATE SYSTEM

Model Number 110.354

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Insufficient Information (4580)

Event Date 11/17/2021

Event Type  malfunction  

Event Description

It was reported that an assure plate had loosened post operatively.This event occurred in (b)(6).

Manufacturer Narrative

Neither device or any imaging could be provided for evaluation.No determinations can be made as to the cause of the reported issue.

Event Description

It was reported that a revision surgery was completed due to an assure plate being loose post operatively.This event occurred in italy.

Manufacturer Narrative

Neither device or any imaging could be provided for evaluation.No determinations can be made as to the cause of the reported issue.

• Brand Name: ASSURE ANTERIOR CERVICAL PLATE SYSTEM
• Type of Device: CERVICAL PLATE
• 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 ; 6109301822
• MDR Report Key: 12844956
• MDR Text Key: 282108046
• Report Number: 3004142400-2021-00230
• 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: D066562
• 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,Followup
• Report Date: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• 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?: No
• Date Manufacturer Received: 11/03/2021
• 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