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

Model Number	436-0354
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The explanted hardware was not returned for evaluation.The identifying lot number was not provided; therefore, a review of device history records cannot be performed.Radiograph images confirmed the screw backout.Based on the current information provided, the root cause cannot be determined.Warnings/cautions/precautions: 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: 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, vibration motion, fall, jolts or other movements preventing proper healing and/or fusion development.Additional or revision surgery may be necessary to correct an adverse effect.
Event or Problem Description
A patient underwent a 3-level anterior cervical discectomy and fusion spinal procedure on an unknown date.Postoperatively, the patient reported pain.Radiograph images revealed one of the inferior screws is backing out.Revision surgery was performed to remove the implanted hardware.

• Brand Name: INSIGNIA
• 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: wesley channell ; 1950 camino vida roble; carlsbad, CA 92008 ; 9014283693
• MDR Report Key: 19482671
• Report Number: 2027467-2024-00055
• Device Sequence Number: 8139345
• Product Code: KWQ
• UDI-Device Identifier: 00190376491226
• UDI-Public: (01)00190376491226
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K213443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/06/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 436-0354
• Device Catalogue Number: 436-0354
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2024
• Initial Report FDA Received Date: 06/07/2024
• 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 Sex: Unknown