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

Catalog Number	2881124
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product is not returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.
Event or Problem Description
It was reported that patient with central stenosis and grade i spondylolisthesis underwent transforaminal interbody fusion at levels l4-l5.Intra -op, cage broke off at 1/3 point where graft containment chamber begins.This occurred during rotation of implant.After placement the surgeon went to rotate the implant and the implant broke.No patient complications were reported.No revision surgery is performed yet.
Additional Manufacturer Narrative
X-ray review: intra operative films for l4-5 transforaminal lumbar interbody fusion show fracture of inter-body device which occurred during an "insert and rotate " technique.This technique is within the described surgical technique and ifu.Potential contributing factors include graft/disc space size mismatch and improper mounting on inserter device.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis : visual and microscopic examination of the returned portion of the implant identified torsional deformation at the inserter interface and vertical shearing of the implant ribs, consistent with torsional overload.The above observations are consistent with torsional overload.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: FUSE ¿ 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: 6566161
• Report Number: 1030489-2017-01222
• Device Sequence Number: 19113336
• Product Code: MAX
• UDI-Device Identifier: 00643169245525
• UDI-Public: 00643169245525
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K121288
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/19/2017

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: 11/14/2024
• Device Catalogue Number: 2881124
• Device Lot Number: 0523936W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2017
• Initial Date Received by Manufacturer: 05/09/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided; 06/19/2017
• Initial Report FDA Received Date: 05/15/2017
• Supplement Report FDA Received Date: 05/15/2017; 06/23/2017; 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR