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	03/15/2017
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.
Event or Problem Description
It was reported patient underwent posterior lumbar interbody fusion at l3-5.Intra-op, the surgeon implanted two cages on level l4-5 and one was implanted on l3-4.While attempting to implant second elevated cage on l3-4, the cage broke, breaking off a small part of the peek side.No fragments remained inside the patient.No patient complication was reported as the result of the event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: product analysis :visually confirmed peek upper component ears broken off and not returned for analysis.Optical and microscopic examination did not identify damage to the nose of the peek upper component.Implant as-received with peek component raised slightly above the nose of the implant.Optical and microscopic examination of the implant identified very light surface marks on the peek scallop features and deformation on one side of the nose of the peek component, consistent with axial loading due to impingement of the peek component during attempted intraoperative insertion and subsequent fracture of the implant.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: 6479580
• Report Number: 1030489-2017-00783
• Device Sequence Number: 1198680
• Product Code: MAX
• UDI-Device Identifier: 00643169430785
• UDI-Public: 00643169430785
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/03/2017

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: 06/01/2024
• Device Catalogue Number: 8880923
• Device Lot Number: 0505964W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2017
• Initial Date Received by Manufacturer: 03/15/2017
• Supplement Date Received by Manufacturer: 08/03/2017; 08/03/2017
• Initial Report FDA Received Date: 04/11/2017
• Supplement Report FDA Received Date: 08/08/2017; 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR