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

Model Number	269-100-080
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2021
Type of Reportable Event	Malfunction
Event or Problem Description
When the 80mm c/c blade was attached to the screw shank in-situ, the wing beetle clamp that attaches to the screw shank broke away, completely detaching from the blade, and the blade from the screw shank.This caused a delay in surgery.No patient injury reported.
Additional Manufacturer Narrative
The device has not returned.If any additional information is provided, a supplemental report will be submitted.

• Brand Name: SIGMA TLIF ACCESS SYSTEM
• Common Device Name: RETRACTOR
• Manufacturer (Section D): ALPHATEC SPINE, INC; 1950 camino vida roble; carlsbad CA 92008
• Manufacturer Contact: wes channell ; 1950 camino vida roble; carlsbad, CA 92008
• MDR Report Key: 12701176
• Report Number: 2027467-2021-00068
• Device Sequence Number: 12140366
• Product Code: GAD
• UDI-Device Identifier: 00190376270739
• UDI-Public: 00190376270739
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 269-100-080
• Device Catalogue Number: 269-100-080
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2021
• Initial Report FDA Received Date: 10/26/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Female