MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Catalog Number	3120515
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the r reported event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient was pre-operatively diagnosed with degenerative disc disease and underwent anterior cervical discectomy and fusion.Post-op, screw backed-out.No patient complications were reported as a result.No revision surgery was scheduled.
Additional Manufacturer Narrative
X-ray review: a single post-op x-ray was provided for long segment anterior cervical fusion.Image provided was of low quality.Fusion status is unknown.At the bottom level, one of the screws was backed out.This may have been caused by a failure of fusion at one of the segments in this long construct or failure to properly lock screw in plate.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• MDR Report Key: 7103600
• Report Number: 1030489-2017-02482
• Device Sequence Number: 16339032
• Product Code: KWQ
• UDI-Device Identifier: 00613994241146
• UDI-Public: 00613994241146
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K063100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2018

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 Catalogue Number: 3120515
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/15/2017
• Supplement Date Received by Manufacturer: 01/12/2018
• Initial Report FDA Received Date: 12/11/2017
• Supplement Report FDA Received Date: 01/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR