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

Catalog Number	7770828
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/31/2018
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 transforaminal lumbar interbody fusion (tlif) at l5/s1 due to disc herniation.Intra-op, during implantation, the peek portion of the cage broke off.No patient symptoms or complication were reported as result of this event.
Additional Manufacturer Narrative
Product analysis result: visual optical microscopic visual review of the implant confirmed both ¿ears¿ of the top section ((b)(4)) component are broken off and not returned for analysis.Microscopic examination of the top component identified material deformation, suggesting physical obstruction during attempted implantation which prevented full insertion into the vertebral disc space.Visual, optical and microscopic examination of the front-facing tab on the -03 peek top component did not identify witness marks or deformation.The above observations are consistent with partial opening of implant prior to insertion and/or insufficient disc space preparation/distraction, resulting in subsequent implant fracture due to overload during attempted implantation.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: 7909154
• Report Number: 1030489-2018-01290
• Device Sequence Number: 1399856
• Product Code: MAX
• UDI-Device Identifier: 00643169430648
• UDI-Public: 00643169430648
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K142559
• 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): 12/18/2018

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: 05/18/2025
• Device Catalogue Number: 7770828
• Device Lot Number: 0567842W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2018
• Initial Date Received by Manufacturer: 08/31/2018
• Supplement Date Received by Manufacturer: 11/19/2018
• Initial Report FDA Received Date: 09/26/2018
• Supplement Report FDA Received Date: 12/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1