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

Catalog Number	8880923
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device 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 the patient underwent posterior lumbar interbody fusion (plif) due to stenosis.During insertion, the spacer broke.No fragment of the broken implant remained in the patient.No patient complications were reported as a result of this event.
Additional Manufacturer Narrative
The spacer was returned with both ears broken off the peek portion of the implant.The spacer had witness marks on the nose and on the backside around the expander screw from where it appeared that the spacer was impacted.The expander screw was fully opened.If the spacer was installed in that configuration, the ears of the implant would fail due to the pressure placed on them from the tip.The peek portion had pulled away from the titanium portion at the connecting pin consistent with the spacer being expanded.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: 6953930
• Report Number: 1030489-2017-02212
• Device Sequence Number: 795098
• Product Code: MAX
• UDI-Device Identifier: 00643169430785
• UDI-Public: 00643169430785
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K172199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2018

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: 06/20/2024
• Device Catalogue Number: 8880923
• Device Lot Number: 0494724W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2018
• Initial Date Received by Manufacturer: 09/26/2017
• Supplement Date Received by Manufacturer: 02/06/2018
• Initial Report FDA Received Date: 10/17/2017
• Supplement Report FDA Received Date: 02/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1