MAUDE Adverse Event Report: K2M INC. YUOKON OCT SPINAL SYSTEM; SPINAL FIXATION SYSTEM

Catalog Number 7601-10001

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Information (3190)

Event Date 02/20/2018

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.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 patient presented with a possible set screw back-out.The patient reportedly had a possible set screw back-out approximately 4 months post-op.

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.The product was not returned to manufacturer for evaluation, and a thorough investigation was completed as the lot number has been identified/confirmed in this case.Since the set screw remains in the patient, no physical, chemical evaluation could be performed, and the root cause of the reported issue could not be ascertained.Insufficient rod reduction could contribute to a compromised rod to screw interface which could have led to the failure.However, a specific cause for this event could not be confirmed.

Event Description

On (b)(6) 2018 it was reported to k2m, inc.That a patient presented with a possible set screw back-out.The patient reportedly had a possible set screw back-out approximately 3 months post-op.

• Brand Name: YUOKON OCT SPINAL SYSTEM
• Type of Device: SPINAL FIXATION SYSTEM
• Manufacturer (Section D): K2M INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer (Section G): K2M INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer Contact: sandra gilbert ; 600 hope parkway se; leesburg, VA 20175 ; 5719192195
• MDR Report Key: 7342478
• MDR Text Key: 103150356
• Report Number: 3004774118-2018-00023
• Device Sequence Number: 1
• Product Code: NKG
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 02/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 7601-10001
• Device Lot Number: FTGG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2017
• 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