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	11/30/2017
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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient underwent transforaminal lumbar interbody fusion at l3/4 due to lumbar spinal canal stenosis.Intra-op, the connection part of peek part and titanium part of the cage was found to be broken.Fragments remained inside the patient.No patient complications were reported as a result of this event.
Additional Manufacturer Narrative
Additional information: device evaluation: visually confirmed -03 peek upper component ears broken off and not returned for analysis.Optical and microscopic examination did not identify damage to the nose of the -03 peek upper component.Implant as-received with -03 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 of the -03 peek component, consistent with axial loading of the -03 peek component during attempted intra operative insertion and subsequent fracture of the implant.It was also noted that in its as returned state the screw that expands the spacer was not fully closed.If the spacer is attempted to be installed in this position the likely hood of the ears being broken increases.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: 7150441
• Report Number: 1030489-2017-02573
• Device Sequence Number: 1173907
• Product Code: MAX
• UDI-Device Identifier: 00643169430785
• UDI-Public: 00643169430785
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172199
• 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): 03/05/2018

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: 09/12/2024
• Device Catalogue Number: 8880923
• Device Lot Number: 0514656W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2018
• Initial Date Received by Manufacturer: 11/30/2017
• Supplement Date Received by Manufacturer: 02/03/2018
• Initial Report FDA Received Date: 12/28/2017
• Supplement Report FDA Received Date: 03/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1