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

Model Number	15610; 15701-065-050
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Fall (1848); Pain (1994)
Date of Event	03/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The implants are currently being evaluated.A follow up report with the results of the investigation will be submitted upon completion.
Event or Problem Description
Around 3-months after undergoing posterior fixation spinal surgery, a patient reported low back pain after sustaining a fall.A radiograph image revealed a tulip disengaged from the screw shank.Revision surgery was performed.
Additional Manufacturer Narrative
Corrected information: h3.Yes.H6.Investigation findings: 3243.Investigation conclusion: 4310, 19.Additional information: b1.Product problem.Visual inspection confirms the complaint.The tulip head has popped off of the screw shank.The construct was rigidly locked down; therefore, the screw was properly assembled and did not cause the disassociation.Based on marks on both devices, it is possible that the construct twisted, causing the screw and tulip assembly to reach max angulation in which the tulip head was forced to pop off from the shank.The disassociation of the tulip and shank was due to excessive loads from the fall of the patient.Review of device history records showed that there were no manufacturing or processing related irregularities.Labeling review: warnings/cautions/precautions: risk factors that may affect successful surgical outcomes include alcohol abuse, obesity, patients with poor bone, muscle and/or nerve quality.Patients who use tobacco or nicotine products should be advised of the consequences that an increased incidence of non-union has been reported with patients who use tobacco or nicotine products.Possible adverse effects: initial or delayed loosening, disassembly, bending, dislocation, and/or breakage of device components.Postoperative management: the surgeon should instruct the patient regarding amount and time frame after surgery of any weight bearing activity.The increased risk of bending, dislocation, and/or breakage of the implant devices, as well as an undesired surgical result are consequences of any type of early or excessive weight bearing, vibratory motion, fall, jolts or other movements preventing proper healing and/or fusion development.Implant devices should be revised or removed if bent, dislocated, or broken.Immobilization should be considered in order to prevent bending, dislocation, or breakage of the implant device in the case of delayed, mal-union, or non-union of bone.Immobilization should continue until a complete bone function mass has developed and been confirmed.

• Brand Name: INVICTUS
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): ALPHATEC SPINE, INC.; 1950 camino vida roble; carlsbad CA 92008
• Manufacturer (Section G): 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: 19028469
• Report Number: 2027467-2024-00021
• Device Sequence Number: 6992550
• Product Code: KWP
• UDI-Device Identifier: 00190376239316
• UDI-Public: (01)00190376239316(10)RE00029;(01)00190376258102(10)TO02511
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K192938
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• 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): 04/02/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: 15610; 15701-065-050
• Device Catalogue Number: 15610; 15701-065-050
• Device Lot Number: RE00029; TO02511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2023
• 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: 55 YR
• Patient Sex: Male