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

Catalog Number	9393011
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/10/2017
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.
Event or Problem Description
Pre-op diagnosis: lumbar 4-5 spinal canal stenosis procedure: lumbar 4-5 decompression fusion it was reported that, intra-op, the device was broken while implanting.The surgeon explanted the device.No fragments remained inside the patient.No patient complications were reported as the result of the event.
Additional Manufacturer Narrative
The product returned is brand new in an unopened box.With the available information we are unable to determine the root cause of the event.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: 6840835
• Report Number: 1030489-2017-01990
• Device Sequence Number: 18998169
• Product Code: MAX
• UDI-Device Identifier: 00613994187642
• UDI-Public: 00613994187642
• 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: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2018

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: 12/30/2024
• Device Catalogue Number: 9393011
• Device Lot Number: H5329473
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2018
• Initial Date Received by Manufacturer: 08/10/2017
• Supplement Date Received by Manufacturer: 04/02/2018
• Initial Report FDA Received Date: 09/04/2017
• Supplement Report FDA Received Date: 04/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1