MAUDE Adverse Event Report: SPINAL ELEMENTS, INC AMENDIA CERVICAL PLATE SYSTEM; ANTERIOR CERVICAL PLATE

Model Number	12-32-4014
Medical Device Problem Codes	Failure to Osseointegrate (1863); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not available for evaluation as the device remains in the patient.Patient is asymptomatic and there is no plan for revision surgery.Radiographs received, noted the c7 inferior bone screw is approximately 1mm proud and slightly above the acp plate.Unknown factors include: patient activity at the time or prior to the event, patient bone quality, the degree of spinal instability, patient compliance with postoperative care instructions, or if the patient sustained a fall/impact of any sort.Root cause of the bone screw loosening is unknown.
Event or Problem Description
Patient underwent an acdf surgery to fuse c4- c7.During a routine two month follow up it was noted via radiograph, that the c7 bone screw was now 1mm proud.Patient in asymptomatic and no current plan for revision.

• Brand Name: AMENDIA CERVICAL PLATE SYSTEM
• Common Device Name: ANTERIOR CERVICAL PLATE
• Manufacturer (Section D): SPINAL ELEMENTS, INC; 3115 melrose drive, suite 200; carlsbad CA 92010
• MDR Report Key: 10508272
• Report Number: 3004893332-2020-00008
• Device Sequence Number: 3032645
• Product Code: KWQ
• UDI-Device Identifier: 00840916102982
• UDI-Public: 00840916102982
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K152455
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/20/2020

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: 12-32-4014
• Device Catalogue Number: 12-32-4014
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2020
• Initial Report FDA Received Date: 09/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR