MAUDE Adverse Event Report: K2M INC. NILE ALTERNATIVE FIXATION SPINAL SYSTEM; BONE FIXATION CERCLAGE

Catalog Number 5416-F04730-SG

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 09/28/2017

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.Given the type of correction and the apparent poor bone quality of the patient, it is likely that the t3 lamina fractured due to the biomechanical loading being applied at that level by the construct.Once the bone fractured, the compression being applied to the laminar hooks was released and the non-ideal contact between the set screws and the rod allowed the laminar hooks to move relative to the rod.

Event Description

On 09.29.2017 it was reported to k2m, inc.That a revision surgery took place in which broken laminar hooks, bands and set screw were removed.Revision surgery took place on (b)(6) 2017.Related to 3004774118-2017-00158, 3004774118-2017-00169 and 3004774118-2017-00170.

• Brand Name: NILE ALTERNATIVE FIXATION SPINAL SYSTEM
• Type of Device: BONE FIXATION CERCLAGE
• 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: 6985338
• MDR Text Key: 90516236
• Report Number: 3004774118-2017-00168
• Device Sequence Number: 1
• Product Code: OWI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143350
• 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: 09/29/2017

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 Expiration Date: 03/16/2021
• Device Catalogue Number: 5416-F04730-SG
• Device Lot Number: EEKP-22975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR