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

Catalog Number	4986855
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/11/2020
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 lateral interbody fusion (olif) at l3/4 due to intervertebral disc degeneration and spinal canal stenosis.Intra-op, at the time of cage insertion, the tip of the cage was around the middle of the vertebral body and it became unable for the cage to enter any more.It was checked that the cage had been cracked, so the cage was removed.Since there were no cages of the same size, the defective cage was replaced with a cage of 50mm and the cage insertion was performed.There were also osteophytes and the bone was hard as well.Scratches were found at titanium coating and cracks slightly ahead of the grip.Scratches were on the threads and deformation at the inserter connection.There was a delay of less than 60 min in overall procedure.There were no complications to the patient as a result of this event.
Additional Manufacturer Narrative
Product analysis results: a visual review of the returned implant identified a portion has been broken.Microscopic examination of the inserter interface identified damage to the threaded hole and deformation on the top face, and fracture on one side around the inserter tang interface, consistent with significant impact and torsional loading.Microscopic examination of the fracture surface of the broken portion of the implant identified a fracture with rays emanating away from the area of crack initiation, consistent with brittle overload.The observations are consistent with impaction 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: 9663852
• Report Number: 1030489-2020-00131
• Device Sequence Number: 501735
• Product Code: MAX
• UDI-Device Identifier: 00643169190511
• UDI-Public: 00643169190511
• 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): 04/09/2020

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: 4986855
• Device Lot Number: H5505371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2020
• Initial Date Received by Manufacturer: 01/11/2020
• Supplement Date Received by Manufacturer: 01/11/2020
• Initial Report FDA Received Date: 02/04/2020
• Supplement Report FDA Received Date: 04/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1