MAUDE Adverse Event Report: MSD DEGGENDORF MFG CRESCENT SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	X0310662
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/14/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product is not returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.
Event or Problem Description
It was reported that patient with lumbar stenosis and degenerative disc disease underwent an unspecified spinal procedure at l5-s1.Intra-op, cage cracked when inserter was malleted.Cage broke into fragments.No fragments of the product remained inside the patient.No patient complications were reported.
Additional Manufacturer Narrative
Product analysis :visual review and microscopic inspection reveals fracture just past the ¿nose¿ of the implant.Microscopic examination of inserter interface posterior nose identified crack originating at the implant inserter interface, suggesting significant impact during attempted insertion.The location and nature of the fracture suggest brittle overload during implantation as the mechanism of failure.

• Brand Name: CRESCENT SPINAL SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MSD DEGGENDORF MFG; wertstrasse 17; deggendorf 94469
• MDR Report Key: 6232188
• Report Number: 1030489-2017-00064
• Device Sequence Number: 857619
• Product Code: MAX
• UDI-Device Identifier: 00613994880239
• UDI-Public: 00613994880239
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2017

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: 07/11/2023
• Device Catalogue Number: X0310662
• Device Lot Number: 76AJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/14/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/09/2017
• Supplement Report FDA Received Date: 01/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1