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	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the device nor films of applicable imaging studies were 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 the patient underwent oblique lumbar interbody fusion (olif) of 2 intervertebral discs and anteroposterior fixation at l3/4/5 due to lumbar spinal canal stenosis.Intra-op, during cage insertion the grasping of the cage got loose suddenly when hitting.The threaded inserter hole of the cage was stripped.It was judged that the grasping part of the inserter and the thread of the cage broke and a new cage in same size was opened to deal with it.The newly opened cage turned to a similar state, but it was inserted as it was.The intervertebral disc space was not narrow, and the surgeon cannot decide the size from 8 or 10 and the cage of 10 was inserted.There was a delay of less than 60 min in overall procedure time as a result of this event.There were no patient complications reported as the result of this event.
Additional Manufacturer Narrative
Product analysis results: visual inspection confirmed the threaded hole of the cage and a few of the gripping ribs have been damaged.Microscopic inspection revealed the material around the threaded hold indicates that the material may have been pulled away.This type of damage is consistent with excessive force applied to the implant during the removal process.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: 9353635
• Report Number: 1030489-2019-01326
• Device Sequence Number: 11286043
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2020

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: 02/25/2020
• Initial Date Received by Manufacturer: 10/23/2019
• Supplement Date Received by Manufacturer: 03/09/2020
• Initial Report FDA Received Date: 11/21/2019
• Supplement Report FDA Received Date: 03/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR