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

Catalog Number	8880823
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/13/2019
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
Pre operative diagnosis: l4/5 l5/s1 listhesis and stenosis procedure: minimally invasive spine surgery (mis) and transforaminal lumbar interbody fusion (tlif) it was reported that, intra-op, posterior part of the peek hinge broke when tried to implant as per surgical technique.It was immediately replaced.No fragments of the broken products remained inside the patient.No patient complications were reported as a result of the event.
Additional Manufacturer Narrative
Product analysis: visual review of the implant confirmed the ears/tabs of the spacer are broken off and not returned for analysis.Visual review also revealed a crack on one side of the implant where the tab broke.Optical inspection did not reveal any signs that could contribute to failure.It appears the tabs of the implant broke from overloading the implants height.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: 8477635
• Report Number: 1030489-2019-00379
• Device Sequence Number: 1515313
• Product Code: MAX
• UDI-Device Identifier: 00643169430778
• UDI-Public: 00643169430778
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 07/03/2019

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 Catalogue Number: 8880823
• Device Lot Number: 0689291W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2019
• Initial Date Received by Manufacturer: 03/13/2019
• Supplement Date Received by Manufacturer: 06/10/2019
• Initial Report FDA Received Date: 04/03/2019
• Supplement Report FDA Received Date: 07/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1