MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CLYDESDALE PTC SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	4986845
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/12/2018
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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that on the patient underwent oblique lumbar interbody fusion (olif) at l3-4-5 due to lumbar spinal canal stenosis.Intra-op, during cage insertion, while inserter was being removed, the grip part of the cage broke.The broken part was removed and as the stability of the cage was high and there was no problem with bone fusion, the cage was not removed and it remained in the patient body.There was a delay of less than 60 min in overall procedure time as a result of this event.No patient symptoms or complications were reported as a result of this event.
Additional Manufacturer Narrative
Product analysis results: visual microscopic visual and microscopic inspection of the implant confirmed the top portion of the implant where the inserter attaches has broken off.The lower part of the implant was not returned for analysis.Microscopic inspection of the fracture surface revealed an uneven surface consistent with material overload.The threads of the implant have also been damaged and deformation noted around the rim of the inserter attachment point.It appears the implant was broken from torsional overload.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: 8018326
• Report Number: 1030489-2018-01428
• Device Sequence Number: 1369408
• Product Code: MAX
• UDI-Device Identifier: 00643169190535
• UDI-Public: 00643169190535
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2019

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: 4986845
• Device Lot Number: H5446829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2019
• Initial Date Received by Manufacturer: 10/12/2018
• Supplement Date Received by Manufacturer: 02/13/2019
• Initial Report FDA Received Date: 10/30/2018
• Supplement Report FDA Received Date: 03/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1