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

Catalog Number	4986840
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/28/2017
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.
Event or Problem Description
It was reported that the patient underwent oblique lumbar interbody fusion (olif) at l3-5 due to lumbar degenerative scoliosis.During insertion, the cage broke.The cage was inserted to inserter for l3/4, it could not be removed from the inserter thereafter.The surgeon tried to remove it forcibly and the edge of the cage broke.The fragments were secured and other than that it remained in the patient.When the same inserter was used for l4/5 to insert the cage, there was no trouble.No patient complications were reported as a result of this event.
Additional Manufacturer Narrative
Product analysis: only a small portion of the cage was returned, ~5mm.The fracture face was consistent with material overload from a bending moment.The threads did visually have some signs of damage, but a functional test revealed that the returned portion could be threaded on to the inserter.If information is provided in the future, a supplemental report will be issued.

• 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: 6978959
• Report Number: 1030489-2017-02251
• Device Sequence Number: 684642
• Product Code: MAX
• UDI-Device Identifier: 00643169190542
• UDI-Public: 00643169190542
• 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: 2017
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/14/2024
• Device Catalogue Number: 4986840
• Device Lot Number: 04CE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2018
• Initial Date Received by Manufacturer: 09/28/2017
• Supplement Date Received by Manufacturer: 04/11/2018
• Initial Report FDA Received Date: 10/26/2017
• 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
• Patient Age: 72 YR