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

Catalog Number	9392507
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the r eported event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient was pre-operatively diagnosed with herniated intervertebral disc and underwent spinal decompression surgery.During surgery, the spacer was broken.The product came in contact with the patient.No fragments of the broken spacer remained in the patient.No patient complications were reported.
Additional Manufacturer Narrative
Product analysis: visual and microscopic examination of the implant displays a brittle fracture with rays emanating towards the inserter interface, and deformation at the inserter attachment hole.This type of fracture is consistent with pressure being placed on the implant during a bending moment and excessive force during implant impaction leading to the overload of the material.The angulation of the fracture lines is also constant with this type of failure.The observations suggest that there may have been insufficient distraction or preparation of the disc space prior to attempted insertion of the implant.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): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• MDR Report Key: 8036729
• Report Number: 1030489-2018-01443
• Device Sequence Number: 1498908
• Product Code: MAX
• UDI-Device Identifier: 00613994187451
• UDI-Public: 00613994187451
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K172199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2019

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 Expiration Date: 03/24/2025
• Device Catalogue Number: 9392507
• Device Lot Number: H5349797
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2019
• Initial Date Received by Manufacturer: 10/10/2018
• Supplement Date Received by Manufacturer: 02/04/2019
• Initial Report FDA Received Date: 11/05/2018
• Supplement Report FDA Received Date: 02/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1