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

Model Number	269-100-080
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/14/2020
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
The retractor was removed and the blade came out of the patient missing the wing.The detached wing was removed from the patient causing over 30 minutes delay in the case.
Additional Manufacturer Narrative
(b)(6) 2021 - atec investigational team spoke with the sales rep concerning the event.The rep stated that the >30 min delay in surgery attributed to this complaint was not due to the blade break or the retrieval of the broken component, but that there were general learnings and surgical challenges that presented the delay.Overall, retrieval of the broken piece was approximately 15 minutes.An evaluation of the returned 80mm blade found it had experienced a failure of the right jaw component (pn 169-102) where it assembles with its 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.

• 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: 11154440
• Report Number: 2027467-2020-00053
• Device Sequence Number: 16791806
• Product Code: GAD
• UDI-Device Identifier: 00190376270739
• UDI-Public: (01)00190376270739(10)8621604
• 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): 12/15/2020

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: 269-100-080
• Device Catalogue Number: 269-100-080
• Device Lot Number: 8621604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2020
• Initial Date Received by Manufacturer: 12/15/2020
• Supplement Date Received by Manufacturer: 12/15/2020
• Initial Report FDA Received Date: 01/12/2021
• Supplement Report FDA Received Date: 01/25/2021
• 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: Hospitalization