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

Catalog Number	8880828
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product is not returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.Submitted product images appear to display implant with the peek upper component broken off.
Event or Problem Description
It was reported that on (b)(6) 2017, intra-op, an 8 mm an expandable lumbar cage broke while inserting into patient before distraction.The product was replaced with an 10 mm cage.The surgery was completed successfully.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Product analysis : visual and microscopic review confirms implant fracture.Implant received in slightly angulated position, with the nose exposed.The component vertical post and the ¿ears¿ of the component broken off, bent and cracked, and not returned for analysis, with rays emanating from the area of fracture origination.The above observations are consistent with significant force and/or complete distraction of the disc space utilized during attempted implantation, which may have contributed to subsequent overload of the implant.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: 6776260
• Report Number: 1030489-2017-01883
• Device Sequence Number: 1615928
• Product Code: MAX
• UDI-Device Identifier: 00643169430815
• UDI-Public: 00643169430815
• Combination Product (Y/N): N
• PMA/510(K) Number: K142559
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2017

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: 02/20/2025
• Device Catalogue Number: 8880828
• Device Lot Number: 0549609W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2017
• Initial Date Received by Manufacturer: 07/17/2017
• Supplement Date Received by Manufacturer: 09/21/2017
• Initial Report FDA Received Date: 08/09/2017
• Supplement Report FDA Received Date: 09/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR