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

Model Number	269-100-070
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The returned device is currently under investigation.A follow up report with results of the investigation will be submitted upon completion.
Event or Problem Description
After removing the device from patient, the surgeon noticed metal debris and damage to the instrument.
Additional 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
• Common Device Name: GAD
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 11348161
• Report Number: 2027467-2021-00003
• Device Sequence Number: 4107978
• Product Code: GAD
• UDI-Device Identifier: 00190376270722
• UDI-Public: (01)00190376270722(10)8621603
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Initial Date Received by Manufacturer: 01/28/2021
• Supplement Date Received by Manufacturer: 01/28/2021
• Initial Report FDA Received Date: 02/19/2021
• Supplement Report FDA Received Date: 03/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 57 YR