MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. ALTERA; ALTERA SPACER, 10X31, 8-12MM, 8 DEG

Model Number 1124.1111

Device Problem Dull, Blunt (2407)

Patient Problem Failure of Implant (1924)

Event Date 10/17/2023

Event Type  malfunction  

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.The device was not available for evaluation.Images of the inserter and implant assembly were provided.It can be seen that the drive nut on the implant is not engaged with the driver shaft of the inserter assembly.It is possible that the drive features were not properly aligned before threading the implant onto the inserter, causing implant expansion to not be possible.However, since implant was not returned for evaluation no determinations could be made as to the cause of the reported issue.The following sections are been updated: b4, e1, h2, h6, h10.

Event Description

It was reported that an altera spacer was left in the patient post operatively after it did not expand.This event occurred in japan. .

• Brand Name: ALTERA
• Type of Device: ALTERA SPACER, 10X31, 8-12MM, 8 DEG
• 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: 18811048
• MDR Text Key: 336591186
• Report Number: 3004142400-2023-00203
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140411
• 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: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1124.1111
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/24/2023
• 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
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Race: Asian