MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. INDEPENDENCE MIS; LUMBAR ANCHOR

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Manufacturer Narrative

The device was not available for evaluation as it remains in the patient.Imaging provided shows a lumbar anchor with a distinct offset suggesting the anchor has sheared in the inferior body.However, the exact cause of the reported issue could not be determined.

Event Description

It was reported that an independence mis anchor has broken 2 years post operatively.

• Brand Name: INDEPENDENCE MIS
• Type of Device: LUMBAR ANCHOR
• 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: 13806217
• MDR Text Key: 293308420
• Report Number: 3004142400-2022-00039
• Device Sequence Number: 1
• Product Code: OVD
• 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: 03/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/21/2022
• 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