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

Catalog Number 7601-54080

Device Problem Unintended Movement (3026)

Patient Problem No Information (3190)

Event Date 09/27/2017

Event Type  Injury  

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.A review of all applicable material, inspection, manufacturing, and distribution records according to the description of the product(s) used was conducted.All records revealed that all product(s) lots were manufactured within specifications and distributed in accordance with all operating procedures.The patient was treated for congenital scoliosis, and the complexity of the deformity coupled with anatomical constraints prohibited screws from being inserted at every level of the construct.The limited screw density and complex deformity resulted in an uneven distribution of stress, and the axial slip was isolated to the screw carrying the most significant load.Wear patterns on the cut end of the rod indicate that this is where the axial slip occurred.The length and width of this pattern indicate that the set screw was fully seated on the rod when slip occurred.The manufactured end of the rod included two small deformities, which are consistent with a set screw being fully reduced onto the rod.No indications of axial slip were evident at these locations.

Event Description

On (b)(6) 2017 it was reported to k2m, inc.That a revision surgery would take place for rod slippage.Revision surgery took place 09.27.2017.(related to 3004774118-2017-00151 and 3004774118-2017-00153).

• Brand Name: YUKON 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: 6984756
• MDR Text Key: 90470969
• Report Number: 3004774118-2017-00152
• 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
• Report Date: 09/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 7601-54080
• Device Lot Number: FRNR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2017
• 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
• Treatment: 7601-05026 LOT FUWB; 7601-10001 LOT FTGG
• Patient Outcome(s): Required Intervention
• Patient Age: 3 YR