MAUDE Adverse Event Report: SEASPINE INC. VENTURA NANOMETALENE; IMPLANT

Model Number	33-7415
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Implant Pain (4561)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No injury has been reported; post-explantation pathology review is underway.Inspection of the implant photos provided notes most of the nm surface is not present.No implants have been made available for analysis; conclusion not yet available.Review of labeling: possible adverse events: delayed union or nonunion (pseudarthrosis).
Event or Problem Description
The patient underwent spinal surgery on (b)(6) 2020, l5/s1 plif (caudal to a l1-5 llif) with ventura nanometalene.Upon revision surgery for pseudarthrosis, it was noted that the nanometalane coating had almost completely been removed from the peek interbody.

• Brand Name: VENTURA NANOMETALENE
• Common Device Name: IMPLANT
• Manufacturer (Section D): SEASPINE INC.; 5770 armada drive; carlsbad CA 92008
• MDR Report Key: 10901268
• Report Number: 3012120772-2020-00088
• Device Sequence Number: 2671519
• Product Code: MAX
• UDI-Device Identifier: 10889981151263
• UDI-Public: 10889981151263
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K173260
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 33-7415
• Device Catalogue Number: 33-7415
• Device Lot Number: AU1007343E & AU20559108D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2020
• Initial Report FDA Received Date: 11/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention