MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO 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	08/09/2017
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 preoperative diagnosis of spinal canal stenosis and kyphosis underwent oblique lumbar interbody fusion (olif).Intra-op, when the spinal cage was tried to be inserted in l1/2 using inserter, it broke near the entrance.Since the intervertebral segment was very tight, the cage was hammered with slightly strong force.The intervertebral disc was so narrowed that a cobb could not be installed on the other side.As ribs and peritoneum disturbed insertion of cage, the cage could not be inserted parallel to the intervertebral disc.The surgeon inserted cage from the caudal side to the cranial side, and cage was broken.This was explanted.Even trial was not carried out.Then, new cage was prepared.In this time, trial was conducted and the tab of the inserter was inserted all the way.As a result, the new one could be inserted successfully.
Additional Manufacturer Narrative
Product analysis: visual and microscopic examination identified a ~4mm portion of the top face of the implant, which interfaces directly with the inserter.Optical and microscopic examination of the returned portion of the implant identified a brittle fracture with rays emanating from the root of the thread tooth, and witness marks on the top face of the implant, consistent with significant force during attempted implantation.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): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• MDR Report Key: 6809421
• Report Number: 1030489-2017-01944
• Device Sequence Number: 999234
• 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
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2017

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: 04/04/2025
• Device Catalogue Number: 4986840
• Device Lot Number: H5340507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2017
• Initial Date Received by Manufacturer: 08/09/2017
• Supplement Date Received by Manufacturer: 10/16/2017
• Initial Report FDA Received Date: 08/22/2017
• Supplement Report FDA Received Date: 10/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1