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	09/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Image review: submitted images appear to display broken implant and damaged instrument thread.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 the patient underwent posterior lumbar interbody fusion (plif) at l4/5 due to spondylolisthesis at l4.During the surgery, spinal cage was broken while it was hammered.When the cage was filled with grafted bone, the anterior of the cage was found to be open.At that point, it had been visually checked that the screw that opens the rear of cage was not turned, so the open part was closed with the surgeon¿s hands and it was inserted.As there was a tilt of the vertebrae like l5/s angle, the anterior of the cage was opened again during insertion and was broken.The surgical site was thoroughly cleaned, but it was unknown whether the fragment(s) was left over or not.When the relevant cage was unpacked, it seemed not to be elevated, and to have its screw protruded.No patient complications were reported as a result of this event.
Additional Manufacturer Narrative
Product analysis: the tabs on the backside of the peak sections have broken off.Damaged to the peek section indicates that the peek section may have come in contact with the walls of the disc space during installation.This can cause the peek section to slide up placing enough pressure on the tabs to break them.The witness marks on the backside of the spacer indicate that force was used in an attempt to install the spacer.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: 6889455
• Report Number: 1030489-2017-02092
• Device Sequence Number: 116259
• Product Code: MAX
• UDI-Device Identifier: 00643169430785
• UDI-Public: 00643169430785
• 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
• Report Date (Section B): 04/16/2018

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: 03/22/2025
• Device Catalogue Number: 8880923
• Device Lot Number: 0555799W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2018
• Initial Date Received by Manufacturer: 09/01/2017
• Supplement Date Received by Manufacturer: 03/20/2018
• Initial Report FDA Received Date: 09/25/2017
• Supplement Report FDA Received Date: 04/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1