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

Catalog Number	2922255
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product is not returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that patient with lumbar stenosis and spondylolisthesis at l4-5 underwent l4-5 oblique lumbar interbody fusion.Intra-op, spacer cracked while attempting to make the orthogonal movement during the implantation process.This was explanted and another cage was implanted.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Additional information: product analysis: visual and microscopic examination of the cage reveal that there is damage to the back side of the cage where it mates to the inserter.The threads are damaged, one of the locating slots has some deformation coming out of the corner the other side as cracked and material has broken away from the cage.The direction and fracture face are consistent with the material failing from a bending moment from angular pressure place on the implant from the inserter.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CLYDESDALE 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: 6809412
• Report Number: 1030489-2017-01942
• Device Sequence Number: 11012732
• Product Code: MAX
• UDI-Device Identifier: 00613994972842
• UDI-Public: 00613994972842
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P000058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/08/2025
• Device Catalogue Number: 2922255
• Device Lot Number: 41DK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2018
• Initial Date Received by Manufacturer: 08/07/2017
• Supplement Date Received by Manufacturer: 03/08/2018
• Initial Report FDA Received Date: 08/22/2017
• Supplement Report FDA Received Date: 03/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR