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

Catalog Number 5416-F04730-SG

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 11/02/2015

Event Type  Injury  

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.The subject product has been received and is currently being evaluated.The manufacturer will provide a supplemental report to include the results of the investigation: a review of all applicable material, inspection, manufacturing, and distribution records according to the description of the products used with the concomitant device(s) would be conducted to determine if products lots were manufactured within specifications and distributed in accordance with all operating procedures.A review of the manufacturing and inspection records would be completed looking for any contributing information/trends.A review of the complaint code trends in case they reveal any contributing information as to the cause of this event.Not returned.

Event Description

It was reported to k2m, inc.On (b)(6) 2015 that a revision surgery took place in which 5 broken 4mm nile bands were removed.The patient reportedly had 5 nile bands break approximately 3 months post-op.Revision surgery took place (b)(6) 2015.

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 products used with the concomitant device(s) was conducted.All records revealed that all products lots were manufactured within specifications and distributed in accordance with all operating procedures.Based on the delamination of the green fibers present on three of the returned pieces and the reported repositioning of the bands during the original surgery, the subject bands were likely overloaded at the position of the initial tightening.A review of the manufacturing and inspection records did not reveal any contributing information/trends.A review of the complaint code trends did not reveal any contributing information as to the cause of this event.

• Brand Name: NILE ALTERNATIVE FIXATION
• Type of Device: BONE FIXATION CERCLAGE
• Manufacturer (Section D): K2M, INC.; 751 miller dr se; suite f1; leesburg VA 20175
• Manufacturer (Section G): K2M, INC.; 751 miller dr se; suite f1; leesburg VA 20175
• Manufacturer Contact: sandra gilbert ; 751 miller dr se; suite f-1; leesburg, VA 20175 ; 5719192000
• MDR Report Key: 5245904
• MDR Text Key: 32001741
• Report Number: 3004774118-2015-00059
• Device Sequence Number: 1
• Product Code: OWI
• UDI-Device Identifier: 10888857000025
• UDI-Public: 10888857000025
• 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,Followup
• Report Date: 11/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/09/2016
• Device Catalogue Number: 5416-F04730-SG
• Device Lot Number: DHWC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2015
• 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