MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. REVERE; REVERE® 5.5 THREADED LOCKING CAP

Model Number 524.100

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

Patient Problem Pain (1994)

Event Date 10/16/2020

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 spain that a revision was done due to locking caps that came loose post-operatively with subsequent rod migration out of the screw head causing patient pain.

• Brand Name: REVERE
• Type of Device: REVERE® 5.5 THREADED 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: 11102132
• MDR Text Key: 225792998
• Report Number: 3004142400-2020-00185
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 00889095160246
• UDI-Public: 00889095160246
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133350
• 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

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 524.100
• Device Lot Number: JNV324JA/JNV022AA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/03/2020
• 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