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

Catalog Number	X0909604
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/26/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Submitted images appear to display broken vertebral spacer.
Event or Problem Description
Pre-operative diagnosis: degenerative disc disease procedure: oblique lumbar interbody fusion levels: l2-3, l3-4, l4-5 it was reported that intra-op, after a failed attempt of cage placement, another cage was then attempted for implantation.The cage broke but was impacted enough into the space that it was left implanted in its broken condition.Broken fragment was removed but bulk of implant was left inside patient.No patient complications were reported.
Additional Manufacturer Narrative
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: 6188384
• Report Number: 1030489-2016-03452
• Device Sequence Number: 16360216
• Product Code: MAX
• UDI-Device Identifier: 00613994704962
• UDI-Public: 00613994704962
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K083026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2016

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 Catalogue Number: X0909604
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/26/2016
• Supplement Date Received by Manufacturer: 11/26/2016
• Initial Report FDA Received Date: 12/20/2016
• Supplement Report FDA Received Date: 09/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR