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

Device Problems Patient-Device Incompatibility (2682); Appropriate Term/Code Not Available (3191)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 07/20/2021

Event Type  malfunction  

Manufacturer Narrative

Neither device or any imaging could be provided for evaluation.The rod to rod connectors that caused the metallosis reactions were removed to prevent any further metal reaction in the patient.No complications were reported with the revision surgery.

Event Description

It was reported that a revision was completed to remove revere rod to rod connectors due to patient reaction to implant, metallosis reaction.

• Brand Name: REVERE STABILIZATION SYSTEM
• Type of Device: REVERE ROD TO ROD CLAMP
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• Manufacturer (Section G): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• Manufacturer Contact: daniel paul ; 2560 general armistead avenue; audubon 19403 ; 6109301800
• MDR Report Key: 12536239
• MDR Text Key: 274520579
• Report Number: 3004142400-2021-00181
• 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: 09/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/02/2021
• 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