MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CRESCENT SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	9393012
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/29/2019
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 lumbar laminectomy and decompression, nucleus pulposus exploration and removal, internal fixation through the pedicle system, spondylolisthesis reduction, intervertebral fusion and bone graft fusion due to lumbar spondyl olisthesis, lumbar spinal stenosis, osteoarthritis and chronic pelvic inflammatory disease.Intra-op, when half of the implant was driven into the fusion cage, prosthesis got cracked and the holding part broke because of which all the implants were removed.No patient complications were reported.
Additional Manufacturer Narrative
Product analysis results: visual and optical inspection revealed the implant was returned fractured into multiple pieces.Initiating fracture appears to be near the ¿nose¿ of the implant, suggesting significant impact during insertion.A portion of the implant that connects to the nose was not returned.Macroscopic examination of inserter interface posterior nose did not identify any cracks emanating at the implant inserter interface.The location and nature of the fractures suggest brittle overload during implantation as the mechanism of failure.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CRESCENT SPINAL SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 9108004
• Report Number: 1030489-2019-01053
• Device Sequence Number: 1984817
• Product Code: MAX
• UDI-Device Identifier: 00613994187659
• UDI-Public: 00613994187659
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K172199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2019

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: 9393012
• Device Lot Number: H5504099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2019
• Initial Date Received by Manufacturer: 08/30/2019
• Supplement Date Received by Manufacturer: 08/30/2019
• Initial Report FDA Received Date: 09/24/2019
• Supplement Report FDA Received Date: 11/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 63