MAUDE Adverse Event Report: MSD DEGGENDORF MFG SOVEREIGN SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	7967810
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemostasis (1895)
Date of Event	12/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Outcomes to adverse event: other: bleeding.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 underwent oblique lumbar interbody fusion due to spondylolisthesis.Intra-operatively, after preparing the instruments for the operation was finished, intervertebral curettage was performed.And when the trial was placed, bleeding occurred from the right common iliac vein.Hemostasis was performed with the floseal and the tachosil immediately and it did not become a big problem.There was no malfunction with the product.There was delay of less than 60 min in overall procedure no other health damage in the patient was reported.

• Brand Name: SOVEREIGN SPINAL SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MSD DEGGENDORF MFG; wertstrasse 17; deggendorf 94469
• MDR Report Key: 9537568
• Report Number: 1030489-2020-00002
• Device Sequence Number: 2334524
• Product Code: MAX
• UDI-Device Identifier: 00613994500922
• UDI-Public: 00613994500922
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K091813
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/02/2020

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: 7967810
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2019
• Initial Report FDA Received Date: 01/02/2020
• 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: Other
• Patient Age: 64 YR