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

Model Number	15004-085-090
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The explanted rod did not return to atec.The explanted screw is currently being evaluated.A follow-up report with results of the investigation will be submitted upon completion.
Event or Problem Description
During a postoperative visit, radiographs revealed the 5.5mm rod fractured at the contralateral s1 screw.In addition, the screw shank had broken free from the tulip head.A revision surgery was performed on (b)(6) 2021 to remove and replace the broken implants.No patient injury reported.
Additional Manufacturer Narrative
Additional information: d4: model# 15260-55-500, udi: (b)(4).Health effect- clinical code: 4582.Health effect- impact code: 4629.Medical device problem code:1260.Component code: 568; 4721.Type of investigation: 3331; 10.Investigation findings: 3243.Investigation conclusions: 22.H10: a 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.The explanted shank is fractured through the neck and into the base of the shank sphere.Collateral surface damage was noted on the screw shank from improvised explantation.The device had been implanted for approximately 5 months at the time of revision/removal.Index surgery trajectory and location are unknown, but screw size (ø8.5mm x 90mm) suggests implantation in either the ilium or 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: KODIAK SPINAL FIXATION SYSTEM
• Common Device Name: 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: 13054599
• Report Number: 2027467-2021-00080
• Device Sequence Number: 14517059
• Product Code: NKB
• UDI-Device Identifier: 00190376136134
• UDI-Public: 00190376136134
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K181677
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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): 11/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 15004-085-090
• Device Catalogue Number: 15004-085-090
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2021
• Supplement Date Received by Manufacturer: 11/22/2021
• Initial Report FDA Received Date: 12/21/2021
• Supplement Report FDA Received Date: 04/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female