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

Model Number	136-2-14014
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No evaluation possible at this time.The implants have not been removed from the patient nor has the identifying lot number(s) been provided.The insignia anterior cervical plate system is intended for anterior fixation to the cervical spine.The insignia anterior cervical plate system consists of a variety of sizes of plates and screws that are manufactured from titanium alloy conforming to astm f136 and are offered non-sterile.The instruments in this system are intended for use in surgical procedures.
Event or Problem Description
Post op images revealed have backed out from both the top and bottom.No revision surgery scheduled at this time.The insignia anterior cervical plate system was originally implanted on (b)(6) 2021.

• Brand Name: INSIGNIA ANTERIOR CERVICAL PLATE SYSTEM
• Common Device Name: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
• Manufacturer (Section D): ALPHATEC SPINE, INC.; 1950 camino vida roble; carlsbad CA 92008
• MDR Report Key: 11569519
• Report Number: 2027467-2021-00009
• Device Sequence Number: 14275663
• Product Code: KWQ
• UDI-Device Identifier: 00190376266169
• UDI-Public: (01)00190376266169
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K200995
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 136-2-14014
• Device Catalogue Number: 136-2-14014(01)
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/25/2021
• Initial Report FDA Received Date: 03/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR