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

Catalog Number	4986050
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis results: visual and microscopic inspection of the implant confirmed the 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.It appears the implant was broken from torsional overload.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient underwent oblique lateral interbody fusion (olif) at l4/5 due to lumbar canal stenosis (lcs).Intra-op, the direction of the cage (the dorsal side and the ventral side) got reversed.After the insertion at l3/4, it was attempted to remove the cage using an instrument of l4/5 standard, but failed.So drilled the cage into small parts and removed the cage.The removed cage was chipped about 1/5 and the remaining parts were missing due to washing.New product was opened and used.There was a delay of more than 60 minutes in overall procedure time as a result of this event.No patient complications were reported.

• 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: 9301800
• Report Number: 1030489-2019-01294
• Device Sequence Number: 2509155
• Product Code: MAX
• UDI-Device Identifier: 00643169190726
• UDI-Public: 00643169190726
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/09/2019

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: 4986050
• Device Lot Number: H5510808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2019
• Initial Report FDA Received Date: 11/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1