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

Model Number	436-0234;126-PRO-08141207-S
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023, a patient underwent a 2-level anterior cervical discectomy and fusion procedure.At the 6-week postoperative visit, a radiograph revealed a screw backout at the inferior level, along with subsidence of the cage at c6-c7.Revision surgery is planned.
Additional Manufacturer Narrative
The implant remains in the patient.Revision surgery is planned.The identifying lot number was not provided; therefore, a review of the device history record could not be conducted.A postoperative radiograph image was provided which confirm the event.Based on the information provided, a root cause could not be determined.If additional information, a supplemental report will be filed accordingly.

• Brand Name: INSIGNIA
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• 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: 17135961
• Report Number: 2027467-2023-00037
• Device Sequence Number: 6021241
• Product Code: KWQ
• UDI-Device Identifier: 00190376416267
• UDI-Public: (01)00190376491059;(01)00190376416267
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K213443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/15/2023

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: 436-0234;126-PRO-08141207-S
• Device Catalogue Number: 436-0234;126-PRO-08141207-S
• 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: 05/17/2023
• Initial Report FDA Received Date: 06/15/2023
• 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