MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. INDEPENDENCE MIS; THREADED ROD

Model Number 6135.0010

Device Problem Material Fragmentation (1261)

Patient Problem Insufficient Information (4580)

Event Date 03/10/2023

Event Type  malfunction  

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.The device was returned for evaluation.Initial observation shows a fracture at the distal tip just past the first thread.Additional information provided that during implantation, the spacer went laterally off trajectory which prompted the surgeon to remove the cage for repositioning.The surgeon was reported to be rocking the cage laterally and tapping on the inserter to try to loosen the cage in the space.While pulling on the attached inserter the inserter detached revealing the threaded rod had sheared off.It is possible the device had fatigued under regular use resulting in the failure.However, an exact cause of the reported issue could not be determined.The following sections have been updated for this supplemental report: b4, e1, h2, h6, h10.

Event Description

It was reported that during surgery the tip of the threaded rod was broken and left in the patient.

• Brand Name: INDEPENDENCE MIS
• Type of Device: THREADED ROD
• 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: 18822097
• MDR Text Key: 336898958
• Report Number: 3004142400-2023-00047
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160597
• 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: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6135.0010
• Device Lot Number: JNV243BD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2023
• Date Manufacturer Received: 03/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male