MAUDE Adverse Event Report: K2M, INC. MESA SPINAL SYSTEM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number 801-36450M

Device Problems Break (1069); Device Issue (2379)

Patient Problem No Information (3190)

Event Date 01/28/2016

Event Type  malfunction  

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.Since the screw remains in the patient no physical, material, chemical evaluation could be performed, and the exact cause of the reported issue could not be ascertained.A review of the manufacturing and inspection records did not reveal any contributing information/trends.Manufacturer is not expecting additional information and therefore considers this to be a closing report.Not returned.

Event Description

It was reported to k2m, inc.On (b)(6) 2016 that a surgery took place in which the outer collet of a screw sheared off.

• Brand Name: MESA SPINAL SYSTEM
• Type of Device: PEDICLE SCREW SPINAL SYSTEM
• 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: 5462900
• MDR Text Key: 39108079
• Report Number: 3004774118-2016-00007
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141873
• 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: 01/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 801-36450M
• Device Lot Number: CHGW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2014
• 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