MAUDE Adverse Event Report: WARSAW ORTHOPEDICS WAVE D SPINAL SYSTEM

Catalog Number	2660924
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product was not 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 presented with spinal stenosis; and underwent transforaminal lumbar interbody fusion (tlif) at l3-s1.Intra-op, the treated level was extremely collapsed and the markers on the device indicated that the distraction plug of the device was pushed out of the interbody device medially rather than locking into its place anteriorly.No patient complications were reported.No additional treatment was performed as a result of this event.

• Brand Name: WAVE D SPINAL SYSTEM
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 10178781
• Report Number: 1030489-2020-00689
• Device Sequence Number: 19489315
• Product Code: MAX
• UDI-Device Identifier: 00643169245174
• UDI-Public: 00643169245174
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K121333
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/22/2020

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: 10/15/2025
• Device Catalogue Number: 2660924
• Device Lot Number: 0586714W
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2020
• Initial Report FDA Received Date: 06/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Weight: 91