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

Catalog Number 801-05545D

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 03/09/2016

Event Type  malfunction  

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.The product was not returned to manufacturer for evaluation, and a thorough investigation could not be completed as no lot number has been identified/confirmed in this case.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 general review of the manufacturing and inspection records did not reveal any contributing information/trends.

Event Description

It was reported to k2m, inc on (b)(4) 2016 that a mesa screw was unable to be locked during surgery.

• 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: 5551025
• MDR Text Key: 41983914
• Report Number: 3004774118-2016-00020
• Device Sequence Number: 1
• Product Code: MNI
• UDI-Device Identifier: 10888857135628
• UDI-Public: 10888857135628
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112920
• 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: 03/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 801-05545D
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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