MAUDE Adverse Event Report: K2M INC. YUKON OCT SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Catalog Number 7601-03514

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 03/13/2018

Event Type  malfunction  

Manufacturer Narrative

Stryker completed its acquisition of k2m, inc.(k2m) on (b)(6) 2018.As part of integration activities, stryker initiated a retrospective review of product field actions k2m initiated for the period 2016 to 2018.Additionally, stryker spine performed a retrospective review of k2m post market surveillance complaints.The purpose of this review was to assess reportability decisions and ensure consistency with the stryker corporate procedures and policies.As a result of that review, this mdr is being filed.In addition, stryker concluded this required reporting per 21 cfr part 806 to fda (reported (b)(6) 2019).K2m's investigation confirmed there were yukon polyaxial screws in distribution with a manufacturing error that could prevent the screw from mating with the screw inserter or set screw as intended.This error could cause a deformation of the threads and/or an inability of the screw inserter or set screw to fully seat within the polyaxial screw.K2m was aware of one instance of this manufacturing error.K2m notified customers with a recall notification letter dated (b)(6) 2018.The letter instructed customers to locate and segregate recalled product, complete a tracking/verification form, and return the product to k2m.All product was returned/reconciled.All product that was returned as a result of recall-023 and all affected product in k2m's control prior to the recall were scrapped by k2m.

Event Description

A company representative reported that the screw site preparation, the yukon polyaxial screw ø3.5x14 mm was "difficult to load securely the insert driver" the event was noted during a case preparation; there was no patient involvement.The case was successfully executed using alternative screws that were readily available to the physician.There was no harm to the patient as the event was identified preoperatively.

• Brand Name: YUKON OCT SPINAL SYSTEM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): K2M INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer (Section G): STRYKER-SPINE; 600 hope parkway se; leesburg VA 20175
• Manufacturer Contact: margarita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 8950626
• MDR Text Key: 178369850
• Report Number: 3004774118-2019-01069
• Device Sequence Number: 1
• Product Code: KWP
• UDI-Device Identifier: 10888857349315
• UDI-Public: 10888857349315
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171444
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7601-03514
• Device Lot Number: FUVD
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 3004774118-8/29/2019-003
• Patient Sequence Number: 1