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

Catalog Number	2986845
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	11/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Although it is unknown whether the product caused or contributed to the reported event, we are filling this mdr for notification purpose.H6: 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.
Event or Problem Description
It was reported that the patient underwent oblique lumbar interbody fusion (olif) due to lumbar degenerative scoliosis.During the surgery, bleeding occurred suddenly after trial insertion.After the fixation of l1/5 and placing the cage at l1/2, a trial was inserted to l2/3, surgeon installed it slightly forward and then when it was pulled out, bleeding started.About 500 cc bleeding was observed in 2-3 minutes.The surgeon conducted hemostasis using floseal, and inserted an implant.However the surgeon could not insert it in proper position, so the implant was removed as it was installed in anterior direction.Hemostasis was conducted again, and then one size shorter implant was placed.The bleeding was checked before closing the incision, but it was not observed, so the surgery was finished.It is unknown whether the bleeding came from, blood vessels or intervertebral bodies.There was a delay of less than 60 minutes as a result of this event.

• 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: 7081869
• Report Number: 1030489-2017-02446
• Device Sequence Number: 11080917
• Product Code: MQP
• UDI-Device Identifier: 00613994352385
• UDI-Public: 00613994352385
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K083026
• 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): 12/04/2017

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: 2986845
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2017
• Initial Report FDA Received Date: 12/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SPACER
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 42