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

Catalog Number	G3003063
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	01/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient presented with cervical spondylotic myelopathy underwent anterior cervical fusion at levels c5-th1.On an unknown date, post op, the caudal side of plate backed out.Prolonged hospitalization was due to re-operation.Re-fixation was performed by increasing the size of the plate by one size and the screw diameter by one size.Patient issue was resolved.
Additional Manufacturer Narrative
Additional information: x-ray image review: post-op ct/ x-ray from c5-6/c6-7/c7-t1 anterior cervical discectomy fusion show the bottom edge of the plate pulled away from t1.There is a spondylolisthesis at c7/t1.There appears to be flattening of the infusion.Infusion c7 osteophyte to accommodate placement of the plate.It is useless what the intra-op images showed or too soon post-op these were taken.Fusion has not occured in the interbody graft.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ZEVO¿ 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: 7302975
• Report Number: 1030489-2018-00297
• Device Sequence Number: 16712880
• Product Code: KWQ
• UDI-Device Identifier: 00643169327078
• UDI-Public: 00643169327078
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2018

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 Expiration Date: 11/22/2024
• Device Catalogue Number: G3003063
• Device Lot Number: 0524857W
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/30/2018
• Supplement Date Received by Manufacturer: 04/03/2018
• Initial Report FDA Received Date: 02/28/2018
• Supplement Report FDA Received Date: 04/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SCREWS AND SPACER
• Outcome Attributed to Adverse Event: Required Intervention