MAUDE Adverse Event Report: ALPHATEC SPINE, INC. INVICTUS OSSEOSCREW SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	16183-050
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history records found no manufacturing, processing or design related irregularities.The instrument was found to be properly manufactured and released in accordance with the device master record.Visual inspection indicates a clean torsional shear failure.When the internal tension built up from expanding the screw is not relieved by turning the t-handle counter clockwise before removal attempt, a torsional shear failure of the expansion shaft can occur.This is caused by the extra grip on the expansion shaft threads if the shaft is being pulled tightly.
Event or Problem Description
The screw did not expand properly when attempting to remove the expansion shaft from the screw.The tip of the shaft fractured.It was removed from the patient.

• Brand Name: INVICTUS OSSEOSCREW SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): ALPHATEC SPINE, INC.; 1950 camino vida roble; carlsbad CA 92008
• MDR Report Key: 12097114
• Report Number: 2027467-2021-00044
• Device Sequence Number: 1533201
• Product Code: NKB
• UDI-Device Identifier: 00190376307329
• UDI-Public: 00190376307329
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K202327
• 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): 06/01/2021

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
• Operator of Device: No Information
• Device Model Number: 16183-050
• Device Catalogue Number: 16183-050
• Device Lot Number: 8744407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2021
• Initial Report FDA Received Date: 06/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1