MAUDE Adverse Event Report: WARSAW ORTHOPEDICS CRESCENT¿ SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	7770728
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/20/2017
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
It was reported that on (b)(6) 2017, intra-op, at the time of the implanting the cage, the peek portion of the cage completely broke apart from the titanium portion.As a result the surgeon explanted both pieces of the cage.No fragment of the cage remained in patient.No patient complications were reported.
Additional Manufacturer Narrative
Product analysis: visual and microscopic review confirmed implant fracture.Implant received in slightly angulated position, with the nose exposed.The -07 component vertical post and the ¿ears¿ of the -03 component were broken off and not returned for analysis, with rays emanating from the area of fracture origination.The above observations are consistent with significant force and/or complete distraction of the disc space utilized during attempted implantation, which may have contributed to subsequent overload of the implant.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): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 6796534
• Report Number: 1030489-2017-01915
• Device Sequence Number: 831824
• Product Code: MAX
• UDI-Device Identifier: 00643169430655
• UDI-Public: 00643169430655
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K142559
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2017

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: 01/09/2025
• Device Catalogue Number: 7770728
• Device Lot Number: 0538271W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2017
• Initial Date Received by Manufacturer: 07/20/2017
• Supplement Date Received by Manufacturer: 09/21/2017
• Initial Report FDA Received Date: 08/16/2017
• Supplement Report FDA Received Date: 10/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1