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

Model Number	436-0232
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient underwent a 2-level anterior cervical discectomy and fusion spinal procedure on an unknown date.Around 2-months postoperatively, radiograph images revealed a distal right screw backout.Revision surgery was performed to remove the screw.
Additional Manufacturer Narrative
The explanted distal right screw did not return for evaluation.The plate remains in-situ.Radiograph images confirmed the event.The identifying lot number was not provided; therefore, a review of the device history record could not be conducted.The root cause could not be determined.Labeling review: "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: 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: additional or revision surgery may be necessary to correct an adverse effect.".
Additional Manufacturer Narrative
B5.A patient underwent a 2-level anterior cervical discectomy and fusion spinal procedure on (b)(6) 2023.Around 2 months postoperatively, radiographic images revealed a distal right screw backout.Revision surgery was performed on (b)(6) 2023 to remove the screw.D6a.(b)(6) 2023.

• 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: 17839746
• Report Number: 2027467-2023-00064
• Device Sequence Number: 7389801
• Product Code: KWQ
• UDI-Device Identifier: 00190376491042
• UDI-Public: (01)00190376491042
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K213443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2023

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: 436-0232
• Device Catalogue Number: 436-0232
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/28/2023
• Supplement Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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