MAUDE Adverse Event Report: ALPHATEC SPINE, INC. INSIGNIA ANTERIOR CERVICAL PLATE SYSTEM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	436-0238
Medical Device Problem Codes	Break (1069); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The explant is currently being evaluated.A follow-up report with the results of the investigation will be submitted upon completion.
Event or Problem Description
A patient underwent an anterior cervical discectomy and fusion spinal procedure in (b)(6) 2024.It was reported that the locking mechanism failed, and the screw backed out postoperatively.
Additional Manufacturer Narrative
Correction: h3.Yes.H6.Investigation findings: 3252.Investigation conclusions: 4307.Device evaluation: visual inspection confirms that one of the blocker components on the plate has fractured.One of the explanted screws also exhibits significant witness marks on the proximal head surface.Based on the fractured blocker and the witness marks on the screw head, it is likely that the blocker experienced excessive postoperative loads from the screw before fusion.Review of device history records showed no manufacturing or processing related irregularities.Labeling review: warnings/cautions/precautions: without solid bone fusion, this device cannot be expected to support the cervical spine indefinitely and may fail due to bone-metal interface, metal, or bone failure.Based on the fatigue testing results, the physician/surgeon should consider the levels of implantation, patient weight, patient activity level, compliance of the patient, and other patient conditions which may have an impact on the performance and results of this system.No spinal implant can withstand body loads for an indefinite period of time without the support of bone.In the event that successful fusion is not achieved; bending, breakage, loosening, migration and/or disassembly of the device will occur.Potential risks identified with the use of this device, which may require additional surgery, include device component fracture, loss of fixation, non-union, fracture of the vertebrae, and necrosis of bone, neurological injury and vascular or visceral injury.Possible adverse effects: the following complications and adverse reactions have been shown to occur with the use of similar spinal instrumentation.These effects and any other known by the surgeon should be discussed with the patient preoperatively.Initial or delayed loosening, disassembly, bending, dislocation and/or breakage of device components.Postoperative management: the patient should have a complete understanding of and compliance with the purpose and limitations of the implant devices.The surgeon should instruct the patient on how to compensate for any loss in range of spinal motion due to bone fusion.Additional or revision surgery may be necessary to correct an adverse effect.The surgeon should instruct the patient regarding amount and time frame after surgery of any weight bearing activity.

• Brand Name: INSIGNIA ANTERIOR CERVICAL PLATE SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• 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: michael hendrickson ; 1950 camino vida roble; carlsbad, CA 92008 ; 7603566777
• MDR Report Key: 21977652
• Report Number: 2027467-2025-00079
• Device Sequence Number: 18454691
• Product Code: KWQ
• UDI-Device Identifier: 00190376491073
• UDI-Public: (01)00190376491073(10)TO02693
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K213443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• 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): 05/06/2025

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
• Operator of Device: Health Professional
• Device Model Number: 436-0238
• Device Catalogue Number: 436-0238
• Device Lot Number: TO02693
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/09/2023
• 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: 71 YR
• Patient Sex: Male