MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC N/A; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	2981022
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Injury (2348); Blood Loss (2597)
Date of Event	10/23/2017
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.Although it is unknown if the device led to the event or not, we are filing this report for notification purposes.
Event or Problem Description
Pre-operative diagnosis :l3-l5: lumbar canal stenosis, anterior spondylolisthesis with l41 degrees; procedure: l2-l3: laminoplasty, l3-l5: interbody fusion it was reported that during surgery, the dura mater was involved when the trial was pulled out.As a result, the cauda equine nerve was exposed and bleeding started which could not be stopped and exceeded 2500 cc.Surgical site was not visible due to bleeding.No product malfunction was reported.There was a delay of less than 60 minutes in the overall procedure time as a result of this event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: N/A
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 7047778
• Report Number: 1030489-2017-02369
• Device Sequence Number: 1272905
• Product Code: MAX
• UDI-Device Identifier: 00885074088495
• UDI-Public: 00885074088495
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K073291
• 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,Followup
• Report Date (Section B): 11/21/2017

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: 2981022
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/23/2017
• Supplement Date Received by Manufacturer: 10/23/2017
• Initial Report FDA Received Date: 11/21/2017
• Supplement Report FDA Received Date: 11/21/2017
• 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