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

Model Number	15025-075-045
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been returned and is pending evaluation.The root cause is unable to be determined at this time.A supplemental report will be submitted upon completion of device evaluation.
Event or Problem Description
A patient underwent a lumbar spinal fusion surgery on (b)(6) 2020.Postoperatively, it was discovered a screw had fractured.On (b)(6) 2021, a revision surgery was performed to remove the screw.No patient injury reported.
Additional Manufacturer Narrative
Corrected data: d4.Model # 15025-075-040; 15025-075-045 lot# 8375406; 8208209s3 d9.Yes.Additional information: h3.Yes h6.Medical device problem code:1260 "component" code:568 type of investigation: 10 ; 3331 investigation findings: 3243 conclusion 19.H10.The device history records were reviewed and found no anomalies with the manufacturing of both implants.Only the fractured tulip heads were returned.Both had some nicks and scratches present from in-situ removal during revision.F1717 dynamic loading testing was performed on a construct using similar screw (7.5mm x 35mm).The screw shank failure is consistent with the returned tulip heads which was observed at 3.5 million cycles at 150 newtons.When the screw shank cam pocket is aligned perpendicular to the construct rods, failure can occur at the cam pocket cut.
Additional Manufacturer Narrative
H6: health effect- clinical code: 4582.Investigation conclusion: 22.H10: the device history records were reviewed and found no anomalies with the manufacturing of both implants.Only the fractured tulip heads were returned.Both had some nicks and scratches present from in-situ removal during revision.F1717 dynamic loading testing was performed on a construct using similar screw (7.5mm x 35mm).The screw shank failure is consistent with the returned tulip heads which was observed at 3.5 million cycles at 150 newtons.It is unknown when the index surgery or revision surgery dates were.Index surgery trajectory and location are also unknown, but screw size (ø7.5mm x 40/45mm) suggests implantation in the sacropelvic region.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
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): ALPHATEC SPINE, INC; 1950 camino vida roble; carlsbad CA 92008
• Manufacturer Contact: jayson alaba ; 1950 camino vida roble; carlsbad, CA 92008 ; 7604946771
• MDR Report Key: 12517081
• Report Number: 2027467-2021-00064
• Device Sequence Number: 3990745
• Product Code: NKB
• UDI-Device Identifier: 00190376117027
• UDI-Public: (01)00190376117027
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K203056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/23/2021

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: 15025-075-045
• Device Catalogue Number: 15025-075-045
• Device Lot Number: 8208209S3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2021
• Supplement Date Received by Manufacturer: 08/23/2021; 08/23/2021
• Initial Report FDA Received Date: 09/22/2021
• Supplement Report FDA Received Date: 11/09/2021; 04/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/09/2019
• 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: Other
• Patient Sex: Unknown