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

Catalog Number	8881128
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/26/2019
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 revision tlif (transforaminal lumbar interbody fusion) and removal hardware with re-instrumentation at l4/5 due to pseudoarthrosis, recurrent radiculopathy.Intra-op, when surgeon placed the device in the disc space and hit the inserter with a mallet, on the third hit the surgeon noticed that the device broke and they pulled the device back and out of incision.Two little pieces of peek material around the hinge area of device were broken off on both sides of device, both peek pieces were accounted for and the device was never implanted into the disc space.So, the device was replaced with another elevate cage.There were no patient symptoms and complication reported as a result of this event.
Additional Manufacturer Narrative
Product analysis results: visual and optical inspection revealed the spacer has been damaged.The tabs/ears of the implant have been broken off.The height screw is able to thread in and out.The tabs appear to be broken due to impact force during insertion process.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: 9620860
• Report Number: 1030489-2020-00101
• Device Sequence Number: 2460762
• Product Code: MAX
• UDI-Device Identifier: 00643169430846
• UDI-Public: 00643169430846
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K172199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2020

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: 8881128
• Device Lot Number: 0744821W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2020
• Initial Date Received by Manufacturer: 12/26/2019
• Supplement Date Received by Manufacturer: 05/04/2020
• Initial Report FDA Received Date: 01/23/2020
• Supplement Report FDA Received Date: 05/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 122