MAUDE Adverse Event Report: ALPHATEC SPINE, INC. INVICTUS; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	55475-105-100
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The implants have not returned for investigation.Photographs were not provided to confirm the event.Review of device history records indicates no manufacturing or processing related irregularities that may have caused or contributed to this event.If the device and/or additional information are supplied a follow-up report will be filed accordingly.
Event or Problem Description
It was reported that two screws broke postoperatively.Revision surgery is scheduled to remove the broken screws.
Additional Manufacturer Narrative
Corrected information: d9.Yes, returned to manufacturer on 05/24/2024.H3.Yes.H6.Type of investigation: 10, 3331.Investigation findings: 3243, 3252.Investigation conclusion: 19.Device evaluation: two tulip heads and one screw shank returned for evaluation.The shank is fractured through the neck and into the base of the shank sphere.The shank head is immobile and has slight deformation on the distal face of the tulip.It is likely the construct load path traveled through the neck instead of through the friction lock between shank head and tulip.This could be a result of repeated cyclic loading to the neck beyond the performance loads for which it was designed.The 2nd tulip appears to have been locked down in an orientation as intended with the friction lock between shank head and tulip taking load.After the initial screw fractured, all the construct loading was placed on the 2nd screw causing it to break.The original screw trajectory and location are unknown.The supporting construct details and patient medical history are also unknown.Based on the available information, the root cause is likely a result of the excessive loading.Labeling review: warnings/cautions/precautions: risks identified with the use of these devices, which may require additional surgery, include device component failure, loss of fixation/stabilization, non-union, vertebral fracture, neurological injury, vascular or visceral injury.Possible adverse effects: initial or delayed loosening, disassembly, bending, dislocation, and/or breakage of device components.Postoperative management: immobilization should be considered in order to prevent bending, dislocation, or breakage of the implant device in the case of delayed, mal-union, or non-union of bone.Immobilization should continue until a complete bone fusion mass has developed and been confirmed.

• Brand Name: INVICTUS
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): ALPHATEC SPINE, INC.; 1950 camino vida roble; carlsbad CA 92008
• Manufacturer (Section G): ALPHATEC SPINE, INC.; 1950 camino vida roble; carlsbad CA 92008
• Manufacturer Contact: wesley channell ; 1950 camino vida roble; carlsbad, CA 92008 ; 9014283693
• MDR Report Key: 19281134
• Report Number: 2027467-2024-00049
• Device Sequence Number: 20416899
• Product Code: KWP
• UDI-Device Identifier: 00190376457390
• UDI-Public: (01)00190376457390(10)TO01447
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K214006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• 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): 05/09/2024

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: 55475-105-100
• Device Catalogue Number: 55475-105-100
• Device Lot Number: TO01447
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/09/2024
• Supplement Report FDA Received Date: 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/28/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown