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	02/13/2018
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-operative diagnosis for this procedure: back <(>&<)> leg pain type of procedure or technique used: transforaminal lumbar interbody fusion levels implanted: l5-s1 it was reported that intra-op, the product broke.No fragment of the product remaining in patient.No patient complications as a result of this event.

• 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: 7338313
• Report Number: 1030489-2018-00390
• Device Sequence Number: 1198246
• Product Code: MAX
• UDI-Device Identifier: 00643169430822
• UDI-Public: 00643169430822
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K142559
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 03/14/2018

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: 08/18/2024
• Device Catalogue Number: 8880928
• Device Lot Number: 0508004W
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2018
• Initial Report FDA Received Date: 03/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1