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

Model Number UNKNOWN

Device Problem Device Slipped (1584)

Patient Problem Insufficient Information (4580)

Event Date 01/17/2023

Event Type  Injury  

Manufacturer Narrative

The device remains in the patient.A review of the device history records was unable to be performed as the part and lot information of the products involved in the event was not provided.A definitive root cause was unable to be determined with the information provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

Event Description

A patient underwent a 4-level anterior cervical discectomy and fusion procedure in (b)(6) 2022.At the 3-month postoperative visit, a radiograph image revealed the inferior level of the plate had subsided into the anterior vertebral body causing the 2 inferior screws to pushout.No additional information was provided.This is 2 of 2 reports being submitted.

• Brand Name: INSIGNIA ANTERIOR CERVICAL PLATE SYSTEM
• 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: 16402075
• MDR Text Key: 309904764
• Report Number: 2027467-2023-00010
• Device Sequence Number: 1
• Product Code: KWQ
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/18/2023
• 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
• Patient Outcome(s): Other