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

Catalog Number	6190077
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.
Event or Problem Description
It was reported that on an unknown date, post-op, the implanted plate broke.No patient complications were reported as a result of this event.The patient does not really want to have any further surgery.
Additional Manufacturer Narrative
Additional information: x-ray image review: x-ray review: "pre-op and post-op x-rays from c3-7 anterior cervical discectomy and fusion revised to c3-t1 fusion with c6-7 corpectomy and posterior instrumentation show fracture of the translational plate.This can happen with sudden/exaggerated cervical extension despite the presence of posterior instrumentation.All hardware appears appropriately placed.Significant deformity correction has occurred possible adding some "pre-stress" to the construct." 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: 6692245
• Report Number: 1030489-2017-01689
• Device Sequence Number: 13586076
• Product Code: KWQ
• UDI-Device Identifier: 00613994235756
• UDI-Public: 00613994235756
• Combination Product (Y/N): N
• Initial Reporter State: AK
• 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): 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: 6190077
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/12/2017
• Supplement Date Received by Manufacturer: 07/11/2017
• Initial Report FDA Received Date: 07/07/2017
• Supplement Report FDA Received Date: 07/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1