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

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Event Description

It was reported by a patient that her rods had broken post-operatively.The patient indicated she has osteoporoisis and has had several surgeries with rods that continue to break.Two 5.5mm straight rods and two 5.5mm curved rods were originally implanted; however, it is unclear which of these is broken.

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.The broken rod was not returned for evaluation as it remains in the patient.No determinations can be made as to the cause of the reported issue.

• Brand Name: REVERE
• Type of Device: REVERE ROD
• 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: 18831944
• MDR Text Key: 336826171
• Report Number: 3004142400-2018-00060
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061202
• 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: 03/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/27/2018
• 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 Sex: Female