MAUDE Adverse Event Report: ALPHATEC SPINE INC INVICTUS SPINAL FIXATION SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 15100

Device Problems Loose or Intermittent Connection (1371); Noise, Audible (3273)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/03/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Revision surgery was conducted on (b)(6) 2020.The left l4 set screw was loose causing the rod to move back and forth.The patient could hear audible squeaking with slight flexion and extension.Set screw, rod, and screw were removed and replaced.The invictus spinal fixation system was implanted on (b)(6) 2020.

Manufacturer Narrative

There were two set screws returned for evaluation.Both are of the same product part number but contain separate identifying lot numbers.It is unknown which belongs to the backed out screw.15100; set screw, lot# sm122537, manufactured 2/29/2020.15100; set screw, lot# 8301101s5, manufactured 7/11/2019.An evaluation of the returned implants found.Set screw 1.Continuous wear on outer circumference of set screw indicates that the rod had contact under force for greater than 360 deg (this is indicative that the set screw was used to reduce a rod).There is symmetric wear mark which indicates that the set screw did have normal contact to the mating rod at full lock down.Note that one side of the wear mark is less pronounced, this indicates that the set screw had more contact on one side than the other.Based on these wear marks, it is inferred that the set screw was used to reduce a non-normal rod causing the wear mark on the outer circumference, but able to have a normalized lock down at final tightening.Set screw 2.Continuous wear on outer circumference of set screw indicates that the rod had contact under force for greater than 360 deg (this is indicative that the set screw was used to reduce a rod).Note that the continuous wear mark ends in a non-symmetric condition; this indicates that the set screw was not normal to the rod at final lockdown.There is a second wear mark located counter-clockwise to the final lockdown position.This wear mark is a result of rod motion relative to the set screw and the counter-clockwise position is in a "loosened" conditioned compared to final lockdown.Based on these wear marks, it is inferred that the set screw did not have a normalized lock down at final tightening, resulting in set screw loosening and rod motion.

• Brand Name: INVICTUS SPINAL FIXATION SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad, ca
• MDR Report Key: 10215352
• MDR Text Key: 197094360
• Report Number: 2027467-2020-00030
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00190376137902
• UDI-Public: (01)00190376137902
• Combination Product (y/n): N
• PMA/PMN Number: K181677
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 15100
• Device Catalogue Number: 15100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2020
• Date Manufacturer Received: 06/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 57 YR