MAUDE Adverse Event Report: ALPHATEC SPINE, INC INVICTUS OCT SPINAL FIXATION SYSTEM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	19003-35-30
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported halfway through insertion a polyaxial screw broke at the junction between the threaded and smooth portion of the screw shank.The threaded portion of the screw shank remains in the vertebral body.A smaller screw was placed adjacent to the broken screw shank.
Additional Manufacturer Narrative
The returned implant is currently being evaluated.A follow-up report with the results of the investigation will be submitted upon completion.
Additional Manufacturer Narrative
H6: investigation findings: 3251.Investigation conclusion: 18, 61.H10: it was reported the surgeon drilled into the bone, did not tap, and then inserted the screw.The surgical technique guide recommends using taps during bone preparation to help create threads withing the bone for screw insertion.Review of the device history record indicates the instrument conformed to dimensional specifications at the time of manufacturing and passed inspection requirements with no non-conformities reported.There were no issues during the manufacture of this product that would contribute to this complaint condition.The proximal portion of the screw returned to alphatec spine for evaluation.Visual inspection found the screw fractured occurred proximally through the threads of the shank.During in-house testing by engineering, 3.5 mm screws were torqued to failure in a vise as well as inserted into 40 and 50 pcf bone foam in order to compare to the complaint failure.The average c3-c7 pedicle bone mineral density is 39.3 pcf per "cervical spine bone mineral density as a function of vertebral level and anatomic location" by william anderst et.Al.This was used a baseline for selecting bone foam density.Results: held in vise: 3.5 mm screws were held ~10 mm from the tip and torqued until failure.-inserted in 40 pcf bone foam (average pedicle density): for 3.5 mm screws no failures were recorded using strictly axial torsion.To force a failure lateral bending was applied.One sample yielded but did not fracture.The other fractured at a value 13% lower than the strict axial torsion.-inserted in 50 pcf bone foam (25% more dense than average): 3.5 mm screws failed in 50 pcf during insertion at approximately the same values as the strict vise-held torsion.The root cause is result of the torsional load exceeded the design limitations for the screw / screw shank.A very high insertion torque may have been applied if the patient had uncharacteristically dense bone.

• Brand Name: INVICTUS OCT SPINAL FIXATION SYSTEM
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• 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: wes channell ; 1950 camino vida roble; carlsbad, CA 92008 ; 9014283693
• MDR Report Key: 17400545
• Report Number: 2027467-2023-00043
• Device Sequence Number: 17644332
• Product Code: NKG
• UDI-Device Identifier: 00190376303864
• UDI-Public: (01)00190376303864(10)8733807
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K203125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 07/26/2023

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: Health Professional
• Device Model Number: 19003-35-30
• Device Catalogue Number: 19003-35-30
• Device Lot Number: 8733807
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2023
• Supplement Date Received by Manufacturer: 06/27/2023
• Initial Report FDA Received Date: 07/26/2023
• Supplement Report FDA Received Date: 09/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/28/2021
• 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
• Patient Age: 60 YR
• Patient Sex: Male