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

Model Number 15025-095-050

Device Problem Fracture (1260)

Patient Problem Bone Fracture(s) (1870)

Event Date 01/11/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The tulip head of the screw broke off the shank while trying to remove it from a patient.

Manufacturer Narrative

H6: health effect- clinical code: 4582.Health effect- impact code: 4629.Medical device problem code:1260.Component code: 568.Type of investigation: 3331; 10.Investigation findings: 3243.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.Non atec extraction device is cold welded to the screw shank.Tulip head was separated from the construct via bolt cutters with rod still locked down in the tulip (with set screw).No evidence of set screw cross threading; set screw is securely locked down.It is unknown when the index surgery or revision surgery dates were.Index surgery trajectory and location are also unknown, but screw size (ø9.5mm x 50mm) suggests implantation in the sacropelvic regions.Supporting construct details and patient physical characteristics are also unknown.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.This can be precipitated by environmental factors such as falls, patient postop weight bearing activity, or other adverse patient events.Other factors that may contribute to complications and adverse reactions (i.E.Construct instability) can include poor fusion development (non-union and/or pseudoarthrosis) or patient bmi.

• Brand Name: INVICTUS 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 roble vida; carlsbad, CA 92008 ; 6624293693
• MDR Report Key: 13552984
• MDR Text Key: 285803751
• Report Number: 2027467-2022-00005
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00190376118994
• UDI-Public: 00190376118994
• 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: 01/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 15025-095-050
• Device Catalogue Number: 15025-095-050
• Device Lot Number: 8784702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2022
• Date Manufacturer Received: 01/18/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/04/2021
• 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 Outcome(s): Other