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

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Manufacturer Narrative

The device could not be returned for evaluation.Imaging provided shows a bilateral rod fracture between l4 and l5 levels and a wedged l4 vertebra.Additional information provided that there was minimal bone formation.In the absence of a fusion, the abnormal anatomy at l4 and the long span of rod on the left side (l3-l5) most likely resulted in the increased stress on the rods; however, an exact cause of the reported issue could not be determined.

Event Description

It was reported that a revere rod was found broken after 7 months post operatively.This event occurred in india.

• Brand Name: REVERE STABILIZATION SYSTEM
• 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: 15845419
• MDR Text Key: 304829450
• Report Number: 3004142400-2022-00172
• 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

• Date FDA Received: 11/22/2022
• 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: 10/26/2022
• 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: 34 YR
• Patient Sex: Female