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	03/13/2017
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.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Pre- op diagnosis: lumbar degeneration it was reported that during surgery, spacer was found to be ruptured.The surgery was successfully completed by replacing the product with a new one.No patient complication was reported as a result of the event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis: visual and microscopic examination of the implant inserter interface features found to be cracked, deformed and deeply gouged, consistent with inappropriate surgical technique.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: 6510537
• Report Number: 1030489-2017-00959
• Device Sequence Number: 16299775
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/20/2017

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: 10/11/2024
• Device Catalogue Number: 9393012
• Device Lot Number: H5309192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2017
• Initial Date Received by Manufacturer: 03/29/2017
• Supplement Date Received by Manufacturer: 09/20/2017; 09/20/2017
• Initial Report FDA Received Date: 04/21/2017
• Supplement Report FDA Received Date: 09/21/2017; 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR