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

Catalog Number	7770923
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product is not returned to manufacturer for evaluation therefore we are not able to determine the definitive cause of event.
Event or Problem Description
It was reported that intra-op, the graft separated and broke apart during spondylolisthesis reduction.It was removed successfully without complications.A new graft was then implanted without issue.There were no patient symptoms or complications as a result of this event.
Additional Manufacturer Narrative
Additional info: product analysis: a visual review of the implant confirmed the ¿ears¿ of the -03-top component are broken off and not returned for analysis.Microscopic review of the returned item indicates that are witness marks on the back side of the implant where it connects to the inserter, indicating force was used in implantation.There do not appear to be any significant witness marks on the nose of the peek portion, this indicates that it would appear the spacer was fully closed.The fracture surface at the ears indicates material overload.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: 6783827
• Report Number: 1030489-2017-01894
• Device Sequence Number: 13604117
• Product Code: MAX
• UDI-Device Identifier: 00643169430686
• UDI-Public: 00643169430686
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K142559
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2017

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: 06/02/2024
• Device Catalogue Number: 7770923
• Device Lot Number: 0486124W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2017
• Initial Date Received by Manufacturer: 08/01/2017
• Supplement Date Received by Manufacturer: 12/20/2017
• Initial Report FDA Received Date: 08/10/2017
• Supplement Report FDA Received Date: 12/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1