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

Catalog Number	3003063
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/04/2018
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.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 cervical degeneration and underwent anterior cervical discectomy and fusion.Post-op, due to non fusion, anterior cervical plate backed out after 6 months.No patient symptoms or complications were reported at this event.No additional treatment or surgery performed as the result of the event.
Additional Manufacturer Narrative
Image review: post op x-ray for c5-t1 acdf and intra-op x-ray shows that the superior screws at c5/c6 along with the plate have backed out.Partial placement appears appropriate.Unable to determine fusion status on provided imaging.Peek interbody graft appears to have been used.There is some subsidence of superior grafts and change in angulation of the screws.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: 8034878
• Report Number: 1030489-2018-01442
• Device Sequence Number: 1303258
• Product Code: KWQ
• UDI-Device Identifier: 00643169329539
• UDI-Public: 00643169329539
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K141632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2018

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: 3003063
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/04/2018
• Supplement Date Received by Manufacturer: 11/27/2018
• Initial Report FDA Received Date: 11/02/2018
• Supplement Report FDA Received Date: 12/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR