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

Device Problems Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported by a representative from (b)(6) that the locking caps came loose post-operatively with subsequent rod migration out of the screw head.

• Brand Name: REVERE
• Type of Device: REVERE LOCKING CAP
• 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: 11102133
• MDR Text Key: 225805732
• Report Number: 3004142400-2020-00184
• 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: 12/30/2020

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: 12/03/2020
• Initial Date FDA Received: 12/31/2020
• 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