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

Catalog Number	4922055
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	08/22/2019
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 whether this product caused or contributed to the reported event, we are filling this mdr for notification purpose.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 (olif) at l4-l5 due to lumbar spinal canal stenosis.Intra-op, at the time of placing the retractor, bleeding was observed on the entry side.It was considered that the bleeding was from the muscles; hence, hemostasis was performed and the bleeding stopped.The surgery was then continued.Wound closure was performed and the patient left the operation room.Post-op, bleeding tendency was confirmed.The surgeon suspected bleeding occurred at somatic arteries.The patient was transferred to another facility; and embolization was performed.Now, the prognosis is good and patient's issue has been reported to have resolved.No malfunction for the reported product has been reported.According to the sales rep, this product was reported as it was a part of the event.

• Brand Name: CLYDESDALE PTC 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: 9114891
• Report Number: 1030489-2019-01060
• Device Sequence Number: 2487195
• Product Code: MAX
• UDI-Device Identifier: 00643169191075
• UDI-Public: 00643169191075
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133205
• 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): 09/25/2019

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 Expiration Date: 01/13/2025
• Device Catalogue Number: 4922055
• Device Lot Number: 67DB
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2019
• Initial Report FDA Received Date: 09/25/2019
• 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