MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. REVERE; REVERE SCREW

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Manufacturer Narrative

The device could not be returned for evaluation as it remains in the patient.Imaging provided was unable to confirm the screw fracture.No determinations could be made as to the cause of the reported issue.

Event Description

It was reported that a revere screw was found broken after 9 months post operatively.This event occurred in india.

• Brand Name: REVERE
• Type of Device: REVERE SCREW
• 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: 15845343
• MDR Text Key: 304829075
• Report Number: 3004142400-2022-00173
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 11/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/26/2022
• Initial Date FDA Received: 11/22/2022
• 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: 63 YR
• Patient Sex: Female