MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. REVERE; 6.5MM REVERE DUAL OUTER DIAMETER POLYAXIAL SCREW, 85MM

Model Number 124.173

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.Evaluation of the returned device shows the screw shank to have sheared approximately 10mm below the screw head.The larger diameter portion of the screw shank has a smooth fracture plane which is consistent with crack propagation associated with fatigue failure.It's possible that high levels of cyclic loading in the lower lumbar spine lead lo fatigue.Additionally, it's possible that the patient did not fully fuse at the instrumented levels leading to higher stress on the hardware.However , the exact cause of th:e reported issue could not be determined.

Event Description

It was reported that the revere screw on the patient's right side broke post-operatively.

• Brand Name: REVERE
• Type of Device: 6.5MM REVERE DUAL OUTER DIAMETER POLYAXIAL SCREW, 85MM
• 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: 18826420
• MDR Text Key: 336874761
• Report Number: 3004142400-2020-00060
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 00084904400046
• UDI-Public: 0084904400046
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061202
• 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: 03/04/2024

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
• Device Model Number: 124.173
• Device Lot Number: BAW138DC
• Initial Date Manufacturer Received: 06/09/2020
• Initial Date FDA Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2019
• 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