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

Catalog Number	8880928
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/22/2018
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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Pre-op diagnosis: lumbar spinal canal stenosis at l4-5 and s1 procedure: transforaminal lumbar interbody fusion it was reported that intra-op, the connection part of the cage broke upon insertion.Fragments were removed from the patient however some might have remained inside the patient.No patient complications were reported as a result of the event.
Additional Manufacturer Narrative
Product analysis: visual and functional inspection of the elevate spacer confirmed the upper component ears/tabs have been broken off and not returned for analysis.Optical and microscopic examination did identify any damage at the bottom or sides of the spacers components.Optical and microscopic examination of the implant identified very light surface marks and rib deformation on the upper peek top.It appears the spacer was overloaded when the spacers height was adjusted while implanted.This is consistent with incomplete distraction/preparation of the disc space prior to attempted implantation of the implant.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis: visual and functional inspection of the elevate spacer confirmed the ears/tabs have been broken off and nor returned for analysis.Optical and microscopic examination did not identify any damage on the bottom or sides of the implant; however, light surface marks and rib deformation was found on the upper peak surface.This damage is consistent with the implant being impacted in a disc space that is not distracted enough to allow the implant to smoothly enter.When the implant is forced in place the distal end of the upper surface plate can be forced upward where the ears/tabs see a load and can break.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: 7863617
• Report Number: 1030489-2018-01232
• Device Sequence Number: 11154755
• Product Code: MAX
• UDI-Device Identifier: 00643169430822
• UDI-Public: 00643169430822
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K142559
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/01/2019

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: 08/09/2024
• Device Catalogue Number: 8880928
• Device Lot Number: 0503479W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2018
• Initial Date Received by Manufacturer: 08/22/2018
• Supplement Date Received by Manufacturer: 12/19/2018; 12/19/2018
• Initial Report FDA Received Date: 09/11/2018
• Supplement Report FDA Received Date: 01/14/2019; 03/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR