MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG 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	11/08/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product is not returned to manufacturer for evaluation therefore we cannot determine the definitive cause of event.
Event or Problem Description
It was reported that patient underwent surgery due to intervertebral disc degeneration.Intra-op, the spacer broke and was replaced by a new one to complete the surgery.No fragments of the product remained inside the patient.No patient complications were reported.
Additional Manufacturer Narrative
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: 6126709
• Report Number: 1030489-2016-03231
• Device Sequence Number: 16426223
• Product Code: MAX
• UDI-Device Identifier: 00613994187659
• UDI-Public: 00613994187659
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K094025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2016

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: 06/08/2023
• Device Catalogue Number: 9393012
• Device Lot Number: H5191245
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/08/2016
• Supplement Date Received by Manufacturer: 11/08/2016
• Initial Report FDA Received Date: 11/24/2016
• Supplement Report FDA Received Date: 09/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 31 YR