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

Model Number 19003-35-30

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/27/2023

Event Type  malfunction  

Event 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.

Manufacturer Narrative

The returned implant is currently being evaluated.A follow-up report with the results of the investigation will be submitted upon completion.

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
• Type of Device: 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
• MDR Text Key: 320133758
• Report Number: 2027467-2023-00043
• Device Sequence Number: 1
• Product Code: NKG
• UDI-Device Identifier: 00190376303864
• UDI-Public: (01)00190376303864(10)8733807
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K203125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 06/27/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/28/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Male