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

Catalog Number	8880828
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/04/2017
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.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
It was reported that patient with disc herniation/spinal stenosis underwent transforaminal lumbar interbody fusion (tlif) at l4/5.Intra-op,when the surgeon inserted the device, half of it sheared off within the disc space.The spacer broke into 3-4 pieces.No patient complications were reported as a result of this event.Additionally it was reported that stiff/immobile disc of patient might have put additional strain on device.
Additional Manufacturer Narrative
Product analysis: visual review confirms implant fracture into multiple pieces with additional deformation noted.Witness mark and material deformation noted on right anterior corner of the top component of the implant, consistent with in vivo obstruction during attempted implantation.It is noted in the fully closed position, the implant nose is protected behind the base component.The component vertical post and the ¿ears¿ of the component broken off and not returned for analysis.Microscopic examination of the fracture surface analysis consistent with brittle overload.The above observations are consistent with partially angulated implant prior to attempted implantation, which may have contributed to subsequent overload of the implant.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: ELEVATE 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: 6528953
• Report Number: 1030489-2017-01045
• Device Sequence Number: 867044
• Product Code: MAX
• UDI-Device Identifier: 00643169430815
• UDI-Public: 00643169430815
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Followup
• Report Date (Section B): 05/30/2017

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: 09/30/2024
• Device Catalogue Number: 8880828
• Device Lot Number: 0519500W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2017
• Initial Date Received by Manufacturer: 04/04/2017
• Supplement Date Received by Manufacturer: Not provided; 05/30/2017
• Initial Report FDA Received Date: 04/28/2017
• Supplement Report FDA Received Date: 06/01/2017; 10/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR