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

Catalog Number	9392508
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/14/2019
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 spinal canal decompression posterior fixation fusion at l4-5, s1 due to spinal stenosis.Intra-op, spacer was deformed at the connection site and fractured during implantation.No any fragments of the implant remaining in the patient body.No patient complications were reported due to this event.
Additional Manufacturer Narrative
Product analysis results: visual and optical inspection confirmed one of the ends of the spacer has been damaged and noticeable witness marks on both sides of the nose of the implant consistent with implanting and removing the implant.Microscopic examination revealed a very rigid fracture surface in multiple areas of the break.There is a crack that spreads from the bottom to the top of the attachment point.This type of damage appears to be consistent with bend stress overload during the implanting/removal process.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: 9449517
• Report Number: 1030489-2019-01409
• Device Sequence Number: 13995008
• Product Code: MAX
• UDI-Device Identifier: 00613994187468
• UDI-Public: 00613994187468
• 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): 03/24/2020

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 Expiration Date: 11/07/2024
• Device Catalogue Number: 9392508
• Device Lot Number: H5318499
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2020
• Initial Date Received by Manufacturer: 11/14/2019
• Supplement Date Received by Manufacturer: 03/12/2020
• Initial Report FDA Received Date: 12/11/2019
• Supplement Report FDA Received Date: 03/24/2020
• 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