MAUDE Adverse Event Report: ALPHATEC SPINE INC SIGMA TLIF ACCESS SYSTEM; GAD

Model Number 269-100-070

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 01/26/2021

Event Type  Injury  

Manufacturer Narrative

The returned device is currently under investigation.A follow up report with results of the investigation will be submitted upon completion.

Event Description

After removing the device from patient, the surgeon noticed metal debris and damage to the instrument.

Manufacturer Narrative

An evaluation of the 70mm blade determined it had experienced a failure of the right jaw component where it assembles with the hinge-pin.This failure mode is consistent with excessive loading of the cross-sectional area between the pin and the jaw.This excessive loading is brought on by over-tightening the blade during initial assembly of the blade to the screw shank component prior to insertion into the surgical site.The stress fracture is then propagated to a full break when the blade is subjected to normal forces during the procedure.All broken pieces of the blade were retrieved from the surgical site, and the or team has been notified about the potential complications of over-tightening during assembly.

• Brand Name: SIGMA TLIF ACCESS SYSTEM
• Type of Device: GAD
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 11348161
• MDR Text Key: 232538829
• Report Number: 2027467-2021-00003
• Device Sequence Number: 1
• Product Code: GAD
• UDI-Device Identifier: 00190376270722
• UDI-Public: (01)00190376270722(10)8621603
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 269-100-070
• Device Catalogue Number: 269-100-070
• Device Lot Number: 8621603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2021
• Date Manufacturer Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR