MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC VERTE-STACK SPINAL SYSTEM; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Catalog Number	2982840
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	02/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Neither the device nor applicable imaging films were 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 underwent anterior lumbar interbody fusion at l1/2 due to lumbar canal stenosis.Intra-op, when operating with the trial, it got in through the facet joint, there was a high possibility of contacting the spinal cord (inferred by the image of frontal and sagittal).The trial was reinstalled in the correct position and the mri was taken after surgery.When taking the mri, it was found that a bone fragment came in contact with the spinal canal and spinal stenosis had occurred, so a posterior laminectomy was performed and the bone fragment was removed.There was no injury to the dura.The patient was transferred to another hospital.Post-operative patient status was unknown.

• Brand Name: VERTE-STACK SPINAL SYSTEM
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 7323644
• Report Number: 1030489-2018-00348
• Device Sequence Number: 110313
• Product Code: MQP
• UDI-Device Identifier: 00885074549873
• UDI-Public: 00885074549873
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K060719
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/08/2018

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: 2982840
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2018
• Initial Report FDA Received Date: 03/08/2018
• 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: Other
• Patient Age: 78 YR