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

Model Number 336-0360;110-PRO-07161407-S

Device Problems Device Slipped (1584); Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/24/2023

Event Type  malfunction  

Manufacturer Narrative

The implant remains in the patient.Radiograph images were provided to confirm the event.The identifying lot number was not provided.Therefore, a review of the device history record could not be conducted.Based on the information provided, a root cause could not be determined.If additional information is provided, a supplemental report will be filed accordingly.Labeling review: "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, infection.".

Event Description

A patient underwent a 3-level anterior cervical discectomy and fusion procedure on (b)(6) 2022.Around 6-months postoperatively, radiograph images revealed a screw back out at the superior level, along with subsidence of the cages.There are no plans for revision surgery.The surgeon will continue to monitor the patient.

• Brand Name: INSIGNIA
• Type of Device: 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: 17191299
• MDR Text Key: 317782995
• Report Number: 2027467-2023-00039
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 00190376420899
• UDI-Public: (01)00190376423661;(01)00190376420899
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K213443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 336-0360;110-PRO-07161407-S
• Device Catalogue Number: 336-0360;110-PRO-07161407-S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1