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 Consequences Or Impact To Patient (2199)
Date of Event	08/15/2017
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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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 on (b)(6) 2017, intra-op, the implant broke upon impaction into l3-4 disc space.After the 9mm x 23mm cage broke, an 8mm x 23mm cage was implanted into the disc space without incident.No patient complications were reported as a result of the event.
Additional Manufacturer Narrative
Product analysis: the spacer was returned with both ears broken off the peek portion of the implant.The peek portion of the implant has separated from the metal portion.The spacer has witness marks on the nose and on the backside around the expander screw from where it appears that the spacer was impacted.Microscopic examination of the implant identified very light surface marks on the peek scallop features of the -03 peek component, consistent with axial loading of the -03 peek component during attempted intraoperative insertion and subsequent fracture of the implant.The root cause of the failure appears to be the result of overload during insertion.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: 6857324
• Report Number: 1030489-2017-02032
• Device Sequence Number: 16308589
• Product Code: MAX
• UDI-Device Identifier: 00643169430785
• UDI-Public: 00643169430785
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K142559
• 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): 05/09/2018

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: 05/16/2025
• Device Catalogue Number: 8880923
• Device Lot Number: 0566256W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2018
• Initial Date Received by Manufacturer: 08/15/2017
• Supplement Date Received by Manufacturer: 04/11/2018
• Initial Report FDA Received Date: 09/12/2017
• Supplement Report FDA Received Date: 05/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 116