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

Catalog Number 5416-F04730-SG

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 03/11/2016

Event Type  Injury  

Manufacturer Narrative

The subject product was returned for evaluation but evaluation is still in progress.Upon completion of evaluation of the subject part, k2m inc.Will file a supplemental report indicating the findings.Evaluation in process.

Event Description

It was reported to k2m, inc on (b)(6) 2016 that a revision surgery took place in which a band fractured post-op.Revision surgery took place (b)(6) 2016.

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.A review of all applicable material, inspection, manufacturing, storage and distribution records according to the description of the product used was conducted.All records revealed that the product lot was manufactured within specifications and distributed in accordance with all operating procedures.A review of the manufacturing and inspection records did not reveal any contributing information/trends.Based on the twisting and fraying observed on the band, it was likely overloaded at the position of the clamp/anatomy interface.

• 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: 5551444
• MDR Text Key: 41990514
• Report Number: 3004774118-2016-00015
• 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,Followup
• Report Date: 03/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 06/26/2020
• Device Catalogue Number: 5416-F04730-SG
• Device Lot Number: DHWD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/11/2016
• Initial Date FDA Received: 04/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2015
• 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
• Patient Age: 13 YR