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

Catalog Number	4986250
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Swelling (2091); Injury (2348)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Although it is unknown whether these products caused or contributed to the reported event, we are filling this mdr for notification purpose.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 l4/5 oblique lumbar interbody fusion(olif) was performed on the anterior due to l4/5 pseudarthrosis.Post-op, the patient was in abdominal discomfort and distension.Ureteral injury was found with contrast examination.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Abdominal distension, ureter injury in patient was observed on (b)(6) 2018.It could be confirmed a duct was on the inter-vertebral disc by visual when dissecting the inter-vertebral disc.The retraction was performed using an elongated rod shaped product called nerve hook which was owned by the hospital.The injury position of ureter was near l4/5.

• 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: 7428018
• Report Number: 1030489-2018-00547
• Device Sequence Number: 1191178
• Product Code: MAX
• UDI-Device Identifier: 00643169190672
• UDI-Public: 00643169190672
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2018

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: 05/11/2025
• Device Catalogue Number: 4986250
• Device Lot Number: 25DS
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/26/2018
• Supplement Date Received by Manufacturer: 03/30/2018
• Initial Report FDA Received Date: 04/13/2018
• Supplement Report FDA Received Date: 04/26/2018
• 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: 60 YR