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

Model Number 136-2-14016

Device Problems Device Dislodged or Dislocated (2923); Material Protrusion/Extrusion (2979)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

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 Description

Post op images revealed the two screw have backed out and are protruding just past the locking mechanism.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
• Type of Device: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
• Manufacturer (Section D): ALPHATEC SPINE, INC.; 1950 camino vida roble; carlsbad CA 92008
• Manufacturer Contact: richard younger ; 1950 camino vida roble; carlsbad, CA 92008 ; 7604946842
• MDR Report Key: 11424235
• MDR Text Key: 242243318
• Report Number: 2027467-2021-00007
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 00190376266183
• UDI-Public: (01)00190376266183
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200995
• 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: 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 136-2-14016
• Device Catalogue Number: 136-2-14016
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR