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	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product is not returned to manufacturer for evaluation but x-rays were reviewed.X-ray review: "post surgery and post op delayed images provided for l2-3, l3-4,l4-5 olif procedure.There appears to be delayed migration of two of the cages from their initial placement.The surgical technique description lists the technique for one or two levels.There appears to be three treated levels in these x-rays.Root cause surgical technique.".
Event or Problem Description
It was reported that patient with kyphosis underwent oblique lumbar interbody fusion.Post op, cages at l4-l5 deviated.No patient complications were reported.No revision surgery is planned so far.
Additional Manufacturer Narrative
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: 6207978
• Report Number: 1030489-2016-03548
• Device Sequence Number: 13580621
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2016

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: 4986250
• Device Lot Number: 13AY
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/05/2016
• Supplement Date Received by Manufacturer: 12/05/2016
• Initial Report FDA Received Date: 12/28/2016
• Supplement Report FDA Received Date: 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1