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

Catalog Number	6190075
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to the manufacturer for evaluation.Review of radiographic images appear to display disassembled anterior cervical plate.
Event or Problem Description
It was reported that the patient presented with cervical stenosis underwent c4-5 corpectomy and c6-7 anterior cervical discectomy with fusion.On (b)(6) 2017, post -op, the plate came apart.No patient complications were reported for this event.
Additional Manufacturer Narrative
Image review: c3-7 anterior cervical discectomy and fusion post-op x-rays show fracture of the translational plate at the motionable segment.Interbody grafts are present at c3-4, c5-6 and c6-7.C4-5 is not instrumented and no fusion is expected to have occurred.This segment is still mobile, eventual deconstruct fracture is the expected result.Root cause: surgical technique.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: 6685557
• Report Number: 1030489-2017-01671
• Device Sequence Number: 13701103
• Product Code: KWQ
• UDI-Device Identifier: 00613994235749
• UDI-Public: 00613994235749
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2017

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: 6190075
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/06/2017
• Supplement Date Received by Manufacturer: 07/11/2017
• Initial Report FDA Received Date: 07/05/2017
• Supplement Report FDA Received Date: 07/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1