MAUDE Adverse Event Report: ALPHATEC SPINE, INC. NVICTUS SPINAL FIXATION SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 15004-095-100;15100;15004-095-100

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Date 03/10/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Approximately 7 months postoperatively, a (b)(6) year old female patient underwent revision surgery due to a nonunion with a broken s2ai screw and contralateral s2ai which also had a set screw disengaged.

Manufacturer Narrative

H6: investigation conclusions: 22.H10: review of the device history records did not identify any manufacturing or processing related irregularities related to the screw shank geometry, tulip geometry, or other physical features.Qir reports indicate all inspected features were acceptable.Material certs were present from the supplier (in compliance with >135 ksi yield strength requirements for shank) along with all other cofc's.No other indications of misuse or heavy wear on the screw tulip exterior, interfacing helical flange threads, or hexalobe-screwdriver interface were observed during evaluation.Explanted shank is fractured through the neck and into the base of the shank sphere.Collateral surface damage noted on screw shank from improvised explantation.The contralateral s2a1 screw with noted set screw disassociation had no remarkable features that would suggest improper lockdown.Rod lock down marks on tulip bushing appeared symmetrical.No evidence of set screw cross threading.For screw fracture: device had been implanted for approximately 7 months at the time of revision/removal.Index surgery trajectory was identified by the rep as s2a1.Failure of the supporting (competitive) expandable interbody likely contributed to an adverse weight bearing load path for the original construct.This failure is consistent with screw failure expectations observed when used in loading conditions that exceed the design parameters set forth in mechanical performance testing.In this instance, the pedicle screw appears to have been exposed to fatigue stresses beyond the performance loads for which it was designed or intended.Other factors that may have contributed to complications and adverse reactions (i.E.Construct instability) would include the poor fusion development (non-union and/or pseudoarthrosis noted in patient history) and by the failure of the supporting interbody expandable.For set screw dislocation: it is reasonable to assume that the initial failure was the screw fracture identified above resulting in severe fixation instability propagating excess loads to other regions of the construct.This would cause atypical and excessive loads on the contralateral s2a1 screw resulting in the observed set screw disassociation.

• Brand Name: NVICTUS SPINAL FIXATION SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): 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: 14068491
• MDR Text Key: 289077625
• Report Number: 2027467-2022-00025
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181677
• 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: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 15004-095-100;15100;15004-095-100
• Device Catalogue Number: 15004-095-100;15100;15004-095-
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2022
• Date Manufacturer Received: 03/10/2022
• Was Device Evaluated by Manufacturer?: No
• 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: 73 YR
• Patient Sex: Female