MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Catalog Number	2982240
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Nerve Damage (1979); Injury (2348)
Date of Event	01/10/2020
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 the patient presented with adult spinal deformity; and underwent oblique lumbar interbody fusion at l2-l3-l4.Intra-op, while using the product, it was confirmed from the image that it had accidentally advanced towards the spinal canal and injured the l2 right nerve root.As a result, bleeding occurred from the epidural vein layer.As the trial shape was dull at that time, the doctor considered that there was no problem and continued the operation.Eventually, nerve palsy was noticed after the operation.According to the nurse in the operation room, there was nerve root injury with the trial and stenosis due to hemostatic material placing.Owing to the technical error by the surgeon, a re-operation was performed on the same day.Nerve injury treatment and hemostasis were performed from posterior side and dura was sewn.

• Brand Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• 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: 9688884
• Report Number: 1030489-2020-00161
• Device Sequence Number: 14301054
• Product Code: MQP
• UDI-Device Identifier: 00885074549804
• UDI-Public: 00885074549804
• 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): 02/10/2020

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 2982240
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2020
• Initial Report FDA Received Date: 02/10/2020
• 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: Life Threatening; Required Intervention