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

Catalog Number	7770728
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/09/2017
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 was pre-operatively diagnosed with lumbar canal stenosis at l2-l3 and posterior spondylolisthesis at l2.Patient underwent transforaminal lumbar inter-body fusion.During surgery, when the surgeon was inserting a cage to intervertebral disc from its peek part (cranial side), the peek part of the cage (especially its tip part) touched the vertebral endplate and broke.The peek part and titanium part got separated.Before insertion, the surgeon expanded the cage to confirm if the functionality would work as intended and after the confirmation he shrunk the cage.There was a delay of less than 60 min in overall procedure time as a result of this event.No broken fragment of the implant remained in the patient.Patient complications were reported as unknown.
Additional Manufacturer Narrative
Product analysis- visual and microscopic examinations were performed.Visual review of the implant confirmed the ¿ears of the -03 top components deformed and broken.Microscopic examination of the -03 peek top component scalloped features did identify and witness marks, suggesting possible physical obstruction during attempted implantation which prevented full insertion into the vertebral disc space.The above observations are consistent with implant fracture due to brittle 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: 7081970
• Report Number: 1030489-2017-02455
• Device Sequence Number: 10988020
• Product Code: MAX
• UDI-Device Identifier: 00643169430655
• UDI-Public: 00643169430655
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K142559
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2018

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: 07/15/2024
• Device Catalogue Number: 7770728
• Device Lot Number: 0500248W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2018
• Initial Date Received by Manufacturer: 11/09/2017
• Supplement Date Received by Manufacturer: 04/09/2018
• Initial Report FDA Received Date: 12/05/2017
• Supplement Report FDA Received Date: 04/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1