MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. REVOLVE; 5.5 MM REVOLVE POLYAXIAL PEDICLE SCREW, 45MM

Model Number 185.455

Device Problem Material Fragmentation (1261)

Patient Problem Failure of Implant (1924)

Event Date 04/26/2016

Event Type  malfunction  

Event Description

It was reported to globus that three months after surgery the patient heard a crack coming from his back upon getting out of the swimming pool.X-ray shows two broken screws.A revision surgery took place on (b)(6) 2017 to remove two revolve screw heads.

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.Visual inspection of both polyaxial screws shows damage at the top of the screw head which most likely occurred during removal of the implants.Based on the information provided and the visual inspection of the implants, it is possible that the screws broke due to excessive stress being applied to the construct.The exact cause of the reported issue cannot be determined.

• Brand Name: REVOLVE
• Type of Device: 5.5 MM REVOLVE POLYAXIAL PEDICLE SCREW, 45MM
• 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: 18809337
• MDR Text Key: 336625345
• Report Number: 3004142400-2016-00017
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083416
• 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: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 185.455
• Device Lot Number: BAS137EE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2018
• Date Manufacturer Received: 04/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2015
• 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: 59 YR
• Patient Sex: Male
• Patient Weight: 79 KG