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

Catalog Number	2968455
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/27/2019
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 presented with lumbar spondylolisthesis (1 degree before l4), lumbar instability (l4-l5), lumbar spinal stenosis (l4-l5) and bone disease.She underwent resection of l4-l5 lumbar disc nucleus pulposes by minimally invasive approach, and cage intervertebral graft fusion, and posterior percutaneous pedicle screw fixation.Intra-op, the cage broke while insertion into the intervertebral space.The cage was then completely explanted and no fragment of the broken cage remained inside the patient.No patient complications were reported.
Additional Manufacturer Narrative
Product analysis: visual and optical examination revealed a 4mm portion of the top part of the implant, which interfaces directly with the inserter has broken off.Macroscopic examination of the returned portion of the implant identified a brittle fracture with rays emanating out form the corners of the implant.There were no witness marks on the outside of the broken portion of the implant.It appears the implant broke due to bend stress overload during the implantation process.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CLYDESDALE 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: 9123710
• Report Number: 1030489-2019-01075
• Device Sequence Number: 2820059
• Product Code: MAX
• UDI-Device Identifier: 00613994486004
• UDI-Public: 00613994486004
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K083026
• 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): 12/05/2019

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: 2968455
• Device Lot Number: H5513375
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2019
• Initial Date Received by Manufacturer: 08/27/2019
• Supplement Date Received by Manufacturer: 11/11/2019
• Initial Report FDA Received Date: 09/26/2019
• Supplement Report FDA Received Date: 12/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR