MAUDE Adverse Event Report: STRYKER-SPINE YUKON OCT SPINAL SYSTEM; APPLIANCE FIXATION SPINAL INTERLAMINAL

Catalog Number 7601-05026

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 04/17/2018

Event Type  malfunction  

Manufacturer Narrative

Stryker completed its acquisition of k2m, inc.(k2m) on (b)(6) 2018.As part of integration activities stryker spine performed a retrospective review of k2m post market surveillance complaints or the period 2017 to 2018.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 (malfunction) is being filed.The instrument was visually and microscopically inspected.Upon review, it was observed that the head had sheared cleanly immediately distal to the screw head.The shear face was shiny and smooth, consistent with the effects of sudden stress fracture.It was confirmed that a 3.5 mm diameter tap was used during the 5.0 mm during screw placement.Utilizing a 4 mm diameter probe or smaller screw diameter may minimalize the compounding forces at the event site during head adjustments.The manufacturing and inspection records were reviewed and no relevant discrepancies were found.

Event Description

A physician reported that a shaft of a yukon screw broke during implant surgery.The device was removed and replaced with a 30 minute delay; surgery was completed with a back-up device.There was no adverse consequences to the patient.

• Brand Name: YUKON OCT SPINAL SYSTEM
• Type of Device: APPLIANCE FIXATION SPINAL INTERLAMINAL
• Manufacturer (Section D): STRYKER-SPINE; 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 07401 ; 2017608000
• MDR Report Key: 8950233
• MDR Text Key: 178370596
• Report Number: 3004774118-2019-01077
• Device Sequence Number: 1
• Product Code: KWP
• UDI-Device Identifier: 10888857350007
• UDI-Public: 10888857350007
• 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
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7601-05026
• Device Lot Number: GGXE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1