MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK VENTURE¿ ANTERIOR CERVICAL PLATE SYSTEM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number	9791221
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
The device was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.X-ray review post-op x-rays for three level anterior cervical discectomy and fusion was provided.We are unable to determine levels from the given images.There is a screw backed out from the inferior level of the construct.There is a paucity of bone present in the grafts.This may be caused by failure of fusion or failure to properly lock plate over screws.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that patient underwent a surgery.Post-op, a screw backed out.As a result, the patient underwent a revision surgery, in which the backed out screw was replaced with a rescue screw.No patient complications were reported as a result of the event.

• Brand Name: VENTURE¿ ANTERIOR CERVICAL PLATE SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• MDR Report Key: 7214586
• Report Number: 1030489-2018-00117
• Device Sequence Number: 143261
• Product Code: KWQ
• UDI-Device Identifier: 00885074529585
• UDI-Public: 00885074529585
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K061274
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/23/2018

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 Catalogue Number: 9791221
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2018
• Initial Report FDA Received Date: 01/24/2018
• 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