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

Catalog Number	7770923
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Injury (2348)
Date of Event	12/14/2018
Type of Reportable Event	Serious Injury
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 intra-op, cage appeared to not be fully collapsed when entering the disc space and it was believed because it was not fully collapsed, the superior portion of the implant captured a portion of the inferior aspect of the l4 vertebral body where it was malleted into place and disrupted the inferior endplate of l4.The peek portion of the cage then fractured and sheared away from the titanium portion of the cage.Dural tear occurred to the patient.The product came in contact with the patient.Patient had a fractured end plate due to this event.
Additional Manufacturer Narrative
Product analysis result: visual functional microscopic visual review of the implant confirmed the ¿ears¿ of the -03-top component are broken off and not returned for analysis.Functional check confirmed the implant screw was able to elevate and lower the upper attachment of the implant.Microscopic review of the returned item indicates that are witness marks on the back side of the implant where it connects to the inserter, indicating force was used in implantation.There does not appear to be any significant witness marks on the nose of the peek portion which indicates the spacer was fully closed.The fracture surface is fairly flat with some raised edges.This type of damage is consistent with material overload.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: 8224520
• Report Number: 1030489-2019-00016
• Device Sequence Number: 265213
• Product Code: MAX
• UDI-Device Identifier: 00643169430686
• UDI-Public: 00643169430686
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K172199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/19/2026
• Device Catalogue Number: 7770923
• Device Lot Number: 0679008W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2019
• Initial Date Received by Manufacturer: 12/14/2018
• Supplement Date Received by Manufacturer: 04/10/2019
• Initial Report FDA Received Date: 01/07/2019
• Supplement Report FDA Received Date: 04/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 74 YR