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

Catalog Number	2621224
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/12/2017
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.
Event or Problem Description
It was reported that the patient underwent a transforaminal lumbar interbody fusion at l5-s1 level due to l5-s1 spinal stenosis and degenerative disc disorder.Intra-op, cage was inserted into the disc space, however device failed to expand correctly.The inner spacer cracked under the stress and tension halfway through expansion.An audible snap was heard.A lateral x-ray showed the cage was broken in the middle.The device was collapsed and completely removed from disk space while still attached to the inserter.The slap hammer was used.Upon immediate review it was obvious that the cage failed under tension.A similar cage was selected and inserted successfully into the disk space.No fragments remained inside the patient.No patient complications were reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis: visual, optical and microscopic examination of the returned implant identified the -02 wedge component fractured near the transition of the wedge from the smaller height to the larger height, with rays emanating near the thin walled centerline of the component, with minimal thread damage below the transition.The above observations are consistent incomplete distraction of the disc space prior to attempted insertion and deployment of the implant, resulting in subsequent intraoperative overload of the implant.If information is provided in the future, a supplemental report will be issued.

• Brand Name: WAVE D 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: 6550859
• Report Number: 1030489-2017-01131
• Device Sequence Number: 16436804
• Product Code: MAX
• UDI-Device Identifier: 00643169245242
• UDI-Public: 00643169245242
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K121333
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/10/2017

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: 10/06/2024
• Device Catalogue Number: 2621224
• Device Lot Number: 0515464W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2017
• Initial Date Received by Manufacturer: 04/12/2017
• Supplement Date Received by Manufacturer: 07/10/2017; 07/10/2017
• Initial Report FDA Received Date: 05/07/2017
• Supplement Report FDA Received Date: 07/18/2017; 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: 50 YR