MAUDE Adverse Event Report: RENOVIS SURGICAL TECHNOLOGIES RENOVIS; TI-6AL-4V ALIF IMPLANT 38 X 30, 13MM 12° LORDOSIS

Catalog Number	1033-383-013
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The operating surgeon informed renovis customer service of a product complaint on (b)(6) 2019.The implants were reported to renovis because, per the complaint, "the surgeon noticed that the alif cage, implanted in 2015, had fractured." the cage was implanted on (b)(6) 2015 and follow-up x-rays taken at the 1-year follow-up show the cage is intact as of that date.The patient complained of severe lower back pain starting approximately two weeks before an office visit on (b)(6) 2018.During this visit, x-rays were taken and show the cage has fractured.X-rays taken at 1-year post-op do not show any signs of cage fracture.In addition, there appears to be fusion at the endplates of the cage but little bony mass visible through the side windows of the cage.X-rays taken at 3-years post-op show the cage fractured in half.The fracture locations are the anterior superior and posterior inferior corners of the lateral graft visualization windows.Based on the 3-year post-op x-ray, the screws and cover plate show no signs of damage or loosening and are therefore excluded from this complaint investigation.The dhr for the fractured cage revealed no non-conformances.In both the 1- and 3-year post-op x-rays, there is little evidence of bony fusion in the graft chamber of the cage.With interbody fusion cages, the long-term goal is bony fusion of the adjacent vertebrae through the graft chamber of the cage.As stated in the potential risks section of ifu for the s 128 alif system (ifu 4128-005) "metallic internal fixation devices cannot withstand activity levels equal to those placed on normal healthy bone.No implant can be expected to withstand indefinitely the unsupported stress of full weight bearing." based on the patient reporting severe pain two weeks before the 3-year follow up, there is evidence to suggest that the cage did not fracture until 3-year post-op.No interbody device is expected to withstand full weight bearing for this period.Renovis will continue to monitor for complaints and take additional action if deemed necessary.If/when renovis is informed of a revision surgery, this complaint investigation will be updated.
Event or Problem Description
While discussing the current alif design with a surgeon, the surgeon stated that a previous alif implant patient had complained of pain in (b)(6) 2018.Upon review of a current x-ray, the surgeon noticed that the alif cage, implanted in 2015, had fractured.Post op x-rays 1 year post-op (2016) showed the cage still intact.The patient was doing well until about a year ago.The patient started experiencing severe back pain about 2 weeks prior to their visit on (b)(6) 2018.The cage failure occurred sometime between 2016 and 2018.

• Brand Name: RENOVIS
• Common Device Name: TI-6AL-4V ALIF IMPLANT 38 X 30, 13MM 12° LORDOSIS
• Manufacturer (Section D): RENOVIS SURGICAL TECHNOLOGIES; 1901 w. lugonia ave.; suite 340; redlands CA 92374
• MDR Report Key: 8299392
• Report Number: 3007932279-2019-00001
• Device Sequence Number: 1991319
• Product Code: OVD
• UDI-Device Identifier: 00841523100675
• UDI-Public: 00841523100675
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K180502
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/01/2019

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: No Information
• Device Expiration Date: 07/01/2019
• Device Catalogue Number: 1033-383-013
• Device Lot Number: 2148-27
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/11/2019
• Initial Report FDA Received Date: 02/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1