MAUDE Adverse Event Report: K2M. INC, A SUBSIDIARY OF STRYKER CORPORATION YUKON OCT SPINAL SYSTEM; APPLIANCE ,FIXATION SPINAL INTERLAMINAL

Catalog Number 7601-04534M

Device Problems Insufficient Information (3190); Migration (4003)

Patient Problem No Information (3190)

Event Date 12/08/2018

Event Type  malfunction  

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.The subject product has not been returned for evaluation yet.Investigation is still in process.When investigation is complete, k2m inc.Will file a supplemental report indicating the findings.

Event Description

On (b)(6) 2018 it was reported to k2m, inc.That a screw backed-out, loosened, disengaged approximately 7-9 months post-operatively.The shaft of the screw remains in the patient.The patient was revised on (b)(6) 2018.

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.The subject product has been returned for evaluation.The head of the screw was returned, visually and microscopically inspected.The components exhibited signs of use, but no abnormal abrasions or damage to the assembly were evident suggesting no misuse of the implant.It is possible that the loading, which took place during the subject surgery, left the assembly in a slightly expanded state.The subsequent loads introduced during revision included an axial component during the reduction step, which may have overloaded the assembly, leading to the reported failure mode.

Event Description

On (b)(6) 2018 it was reported to k2m, inc that.The head of a polyaxial screw disassembled from the shaft intra-operatively during a reduction maneuver.

• Brand Name: YUKON OCT SPINAL SYSTEM
• Type of Device: APPLIANCE ,FIXATION SPINAL INTERLAMINAL
• Manufacturer (Section D): K2M. INC, A SUBSIDIARY OF STRYKER CORPORATION; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 8318536
• MDR Text Key: 135522226
• Report Number: 3004774118-2019-00012
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• PMA/PMN Number: K171444
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 07/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7601-04534M
• Device Lot Number: FUPF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2019
• Date Manufacturer Received: 12/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Weight: 85