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

Catalog Number	7770823
Medical Device Problem Codes	Mechanical Problem (1384); Malposition of Device (2616)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/04/2019
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
It was reported that the patient underwent l4-l5 posterior lumbar interbody fusion.Intra-op, after placing the implant in the disc space at l4-l5, it looked as if the surgeon implanted the cage too far into the disc space.He tried to reconnect the inserter to the implant but was unable to do so.He then collapsed the cage.Retrieval of cage was attempted again but it could not be done.The surgeon then distracted the disc space and tried to reconnect the inserter to the implant.When trying to reconnect the cage to the inserter, the cage was pushed anteriorly, and out of the disc space.No patient complications have been reported currently; however, the patient is going to be evaluated by the surgeon during follow-up.If any symptoms occur from the cage in the anterior space, the surgeon will schedule a surgery by anterior approach to retrieve the implant.

• 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: 8756695
• Report Number: 1030489-2019-00690
• Device Sequence Number: 11148334
• Product Code: MAX
• UDI-Device Identifier: 00643169430440
• UDI-Public: 00643169430440
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K172199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• 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: 7770823
• Device Lot Number: 0696082W
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2019
• Initial 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
• Patient Age: 81 YR