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

Catalog Number	2982040
Medical Device Problem Codes	Use of Device Problem (1670); Difficult to Advance (2920)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	05/21/2020
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 lumbar spinal canal stenosis; and underwent oblique lumbar interbody fusion at l2-l5.Before trial insertion, the distractor had been set to 12 mm, and the trial was started from height of 10 mm.Intra-op, while attempting to insert the trial at l4-l5 at the first level, the trial protruded about 20 mm from the contralateral side as a result of strong hammering.The direction remained diagonal before raising vertically.Strong hammering was performed as the entrance of the intervertebral disc space was narrow.As a result of trial protrusion into the vertebral body, the patient had a lot of bleeding (amount unknown) and hemostasis was performed.Then, the wound was closed without inserting the cage.Originally, it was planned to perform a second stage fixation but it could not be performed then.There was a delay of more than 60 minutes in overall procedure as a result of this event.The surgeon feels that it may have been necessary to start the trial from a smaller size.Although the exact place of bleeding was unknown, the surgeon suspected the bleeding to be from venous plexus near the contralateral route.The surgeon also believes that probably a large vessel was not injured because if it had been a large vessel, hemostasis would have been impossible.Finally, on (b)(6) 2020, posterior lumbar interbody fusion of 3 intervertebral discs was performed and the operation was completed successfully.The amount of bleeding and the patient status remains unknown currently.

• 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: 10177132
• Report Number: 1030489-2020-00673
• Device Sequence Number: 3611249
• Product Code: MQP
• UDI-Device Identifier: 00885074549750
• UDI-Public: 00885074549750
• 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): 06/20/2020

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: 2982040
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2020
• Initial Report FDA Received Date: 06/20/2020
• 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: 75 YR
• Patient Weight: 64