MAUDE Adverse Event Report: ALPHATEC SPINE, INC. INVICTUS SPINAL FIXATION SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION

Model Number	16183-040
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No evaluation possible at this time.The instrument has not been returned nor has the identifying lot number been provided.
Event or Problem Description
Stylet broke during use.The distal tip was not removed from the patient.
Additional Manufacturer Narrative
Atec received a complaint on (b)(6) 2021 that reported while removing the expansion shaft from the expanded osseoscrew, the expansion shaft (referred to as the stylet) broke off at the threads.The tip of the expansion shaft remains entrapped in the implanted osseoscrew.Although the products were not returned for evaluation, an investigation was conducted by the project engineer and determined that this particular occurrence was ultimately a result of user error.The surgical technique provides instruction for releasing the expansion shaft after the screw has been deployed "turn the t handle a full rotation counterclockwise to relieve built up tension.Using the gold release feature on the proximal end of the expansion t handle, press the gold retention ring to release the expansion shaft.After the shaft is released, rotate the shaft counterclockwise to unthread it from the osseoscrew." 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.

• Brand Name: INVICTUS SPINAL FIXATION SYSTEM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): ALPHATEC SPINE, INC.; 1950 camino vida roble; carlsbad CA 92008
• MDR Report Key: 11574233
• Report Number: 2027467-2021-00011
• Device Sequence Number: 3622438
• Product Code: NKB
• UDI-Device Identifier: 00190376307329
• UDI-Public: (01)00190376307329
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K181980
• 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): 02/19/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 16183-040
• Device Catalogue Number: 16183-040
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/25/2021
• Supplement Date Received by Manufacturer: 04/09/2021
• Initial Report FDA Received Date: 03/26/2021
• Supplement Report FDA Received Date: 04/15/2021
• 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