MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. INDEPENDENCE MIS; LUMBAR ANCHOR, 25MM

Model Number 1135.0025

Device Problem Migration (4003)

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 one of the anchors has migrated anteriorly from the cage.The exact cause of the reported issue could not be determined.An operation to remove the anchor was aborted due to concerns for patient safety.

Event Description

It was reported that an independence mis anchor backed out post-operatively.A revision surgery was attempted and was unsuccessful.

• Brand Name: INDEPENDENCE MIS
• Type of Device: LUMBAR ANCHOR, 25MM
• 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: 11276108
• MDR Text Key: 231335219
• Report Number: 3004142400-2021-00020
• 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: 02/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1135.0025
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/07/2021
• 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
• Patient Age: 64 YR