MAUDE Adverse Event Report: WARSAW ORTHOPEDICS ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number	7200085
Medical Device Problem Codes	Use of Device Problem (1670); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Dysphagia/ Odynophagia (1815); Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that on (b)(6) 2017, the patient underwent anterior cervical discectomy and fusion at c3-t1 due to degenerative disc disease and herniated disc.The posterior portion of the surgery was performed on (b)(6) 2017.On an unknown date, post-op, the patient complained of pain, dysphagia and difficulty eating.The patient was not followed up by the operating physician and subsequently ended up in a rehab facility for over a year and lost considerable weight due to inability to eat.As per the reported information, in the initial operation, the operating surgeon had trapped the esophagus under the top part of the plate and inserted one screw which went directly through the esophagus.Only one screw was placed at the top of the plate (at c3) and was not locked down.This screw backed out by 3mm.Hence, on (b)(6) 2018, the revision acdf was performed at c3-t1, in which the plate was explanted and was replaced with plate from another manufacturer.The surgeon (performing the revision) reported that the cause of dysphagia was that the screw was inserted into the esophagus after the plate trapped the esophagus.No patient complications were reported after the revision surgery.
Additional Manufacturer Narrative
Radiological image review result: a single ct film is provided for multi-level anterior/posterior cervico-thoracic stabilization.By report, one of the anterior/superior screws at c3 is backed out.The reported event is not apparent on the provided image.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 INTERVERTEBRAL BODY
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 8100002
• Report Number: 1030489-2018-01528
• Device Sequence Number: 1923745
• Product Code: KWQ
• UDI-Device Identifier: 00613994624949
• UDI-Public: 00613994624949
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K021461
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 7200085
• Device Lot Number: 0579541W
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/30/2018
• Supplement Date Received by Manufacturer: 11/27/2018
• Initial Report FDA Received Date: 11/23/2018
• Supplement Report FDA Received Date: 12/17/2018
• 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: Required Intervention