MAUDE Adverse Event Report: WARSAW ORTHOPEDICS ZEVO ANTERIOR CERVICAL PLATE SYSTEM

Catalog Number	3001015
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
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 on an unknown date in the month of (b)(6) 2019, post-op, the locking mechanism was noticed to be not covering all the screws; and one of the 13mm screws had backed out.Upon explantation, it was seen that the locking mechanism did not sit flush against the plate.There was a single locking mechanism on the 15mm plate.The plate was completely explanted.No patient complications were reported due to this event.
Additional Manufacturer Narrative
Product analysis: visual, optical and microscopic examination of the implant revealed the cap has been bent and witness marks on the outer tabs of the plate cap are consistent with attempting to lock and unlock the plate.Functional evaluation of the locking cap found the cap was not able to be positioned over the bone screw holes.The bone matter appears to be wedged under the cap keeping it from locking and unlocking.Root cause of faulty plate is undetermined.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ZEVO ANTERIOR CERVICAL PLATE SYSTEM
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 9581922
• Report Number: 1030489-2020-00057
• Device Sequence Number: 13619956
• Product Code: KWQ
• UDI-Device Identifier: 00643169329829
• UDI-Public: 00643169329829
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K141632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2020

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: 3001015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2020
• Initial Date Received by Manufacturer: 12/16/2019
• Supplement Date Received by Manufacturer: 04/08/2020
• Initial Report FDA Received Date: 01/13/2020
• Supplement Report FDA Received Date: 04/24/2020
• 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
• Patient Age: 61 YR