MAUDE Adverse Event Report: K2M, INC. PYRENEES CERVICAL PLATE SYSTEM; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Catalog Number 5901-14514C

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 09/28/2015

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 was completed as the lot number has been identified/confirmed in this case.Since the screw has been discarded, no physical, 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.A review of applicable inspection and manufacturing records of possible device manufacturing dates 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 in accordance with all operating procedures.A review of the complaint trends related to this screw did not reveal any contributing information.

Event Description

It was reported to k2m, inc.On (b)(6) 2015 that a surgery took place in which the surgeon was reportedly unable to lock the medial screw into a two-level plate case; the medial plate hole was left open.The surgery took place (b)(6) 2015.

• Brand Name: PYRENEES CERVICAL PLATE SYSTEM
• Type of Device: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
• 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: 5180398
• MDR Text Key: 29348873
• Report Number: 3004774118-2015-00052
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 10888857112810
• UDI-Public: 10888857112810
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150983
• 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: 09/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5901-14514C
• Device Lot Number: DUNF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/28/2015
• Initial Date FDA Received: 10/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2015
• 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
• Treatment: 5908-42F42 LOT DUMV