MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. INDEPENDENCE MIS; LUMBAR ANCHOR, 27MM

Model Number 1135.0027

Device Problem Insufficient Information (3190)

Patient Problem Implant Pain (4561)

Event Date 04/17/2019

Event Type  malfunction  

Event Description

It was reported that a revision was needed to remove an independence mis cage and anchors which were placed laterally in the disc space, towards the patient's left.The patient was experiencing pain post-operatively.The surgeon removed the existing hardware and implanted a new cage and anchors placed more medially.

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.Neither the device or any imaging were available for evaluation.Ii was reported that due to patient anatomy and their access window, the implant was placed further to the left lhan is typical.The patient reported pain post-operatively, and two days following the initial surgery, the independence mis spacer and three accompanying anchors were removed.A smaller footprint spacer was used to get the cage more medial.There was no failure of the device and there have been no additional issues reported.

• Brand Name: INDEPENDENCE MIS
• Type of Device: LUMBAR ANCHOR, 27MM
• 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: 18830951
• MDR Text Key: 336820332
• Report Number: 3004142400-2019-00036
• 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: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1135.0027
• Date Manufacturer Received: 04/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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