MAUDE Adverse Event Report: ALPHATEC SPINE, INC. INVICTUS¿ SPINAL FIXATION SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	15610
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	06/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The implant is currently being evaluated.A follow-up report with the results of the investigation will be submitted upon completion.
Event or Problem Description
During a revision surgery, the surgeon noted a tulip head disassociated from the right s1 screw shank.The hardware was removed from the patient.
Additional Manufacturer Narrative
Additional information: d4.Model# 15704-075-050.Lot# to00143.Udi# (b)(4).H6.Investigation findings: 3207.Conclusion: 61.H10.Observations: the invictus modular polyaxial reduction tulip pn 16510 and modular screw shank pn 15704-075-050 were visually and physically examined and showed no apparent signs of manufacturing defect although both components showed signs of damage during retrieval.A review of the dhrs indicated no remarkable manufacturing or quality items that would have impacted performance relative to the complaint beyond the intended design.There are no clear indications that the design, manufacturing, or initial quality of the implants contributed to the complaint.The invictus modular polyaxial reduction tulip was returned in an undeployed state, meaning that the collet was in its most proximal state.The ring component showed signs of rod contact which indicates that the collet had been properly pushed distally during insertion with the instrument forcing the shank to be captured properly within the assembly and allowing proper rod lockdown.There were no obvious signs within the tulip or on the collet that indicated material was sheared within the tulip or on the collect reflecting that the rod must had lost lockdown force due to set screw backoff resulting in the instability of the screw construct and subsequent release of the shank from the tulip.The internal components show loading indicators and markings from insertion onto the modular shank and lockdown with a rod.The disassembled individual components were reviewed and did not reflect any shearing or deforming outside of the loading conditions.Failure mode and root cause: construct failure due to non-normalization of the rod to screw and set screws interface.Markings depict that proper lockdown was achieved but the rod was not fully normalized to the screws and set screws, creating a construct that with diminished gripping capacity resulting in a possibility of rod slippage.Normalization of the rod is further complicated when fixating and spanning segments with increased lordosis where the polyaxial range of cranial-caudal motion of the screw may limit the ability to fully normalize to the rod as in l5-s1.

• Brand Name: INVICTUS¿ SPINAL FIXATION SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): ALPHATEC SPINE, INC.; 1950 camino vida roble; carlsbad CA 92008
• Manufacturer Contact: wesley channell ; 1950 camino vida roble; carlsbad, CA 92008
• MDR Report Key: 15188500
• Report Number: 2027467-2022-00051
• Device Sequence Number: 6447516
• Product Code: KWP
• UDI-Device Identifier: 00190376239316
• UDI-Public: (01)00190376239316(10)8642105
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K192938
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 07/12/2022

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: 15610
• Device Catalogue Number: 15610
• Device Lot Number: 8642105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2022
• Supplement Date Received by Manufacturer: 07/12/2022
• Initial Report FDA Received Date: 08/08/2022
• Supplement Report FDA Received Date: 09/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/18/2021
• 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 Age: 79 YR
• Patient Sex: Male