MAUDE Adverse Event Report: K2M INC. EVEREST® SPINAL SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number SP-3013-03

Device Problems Fracture (1260); Insufficient Information (3190)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 02/18/2019

Event Type  malfunction  

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.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.

Event Description

On (b)(6) 2019 it was reported k2m, inc.That a cannulated tap broke at the tip during rotating.A portion of the tip remains in the patient.

Event Description

Reported that an everest mi cannulated tap 5.5 mm broke at the tip while rotating and remains in the patient.

Manufacturer Narrative

It was reported that an everest mi cannulated tap broke at the tip while rotating and remains in the patient.The instrument was returned, visually and microscopically inspected.Upon review of the part, it was observed that the threaded feature had sheared at the distal tip.Increased torsional load may have contributed to the failure.Inserting the tap in harder than normal bone can compound torsional forces at the tip, leading to the failure.It was reported that the broken tip remains in the patient.Manufacturing and inspection records of the subject lot were reviewed and no relevant discrepancies were found.

• Brand Name: EVEREST® SPINAL SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 8408749
• MDR Text Key: 138424469
• Report Number: 3004774118-2019-00025
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K181188
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 01/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SP-3013-03
• Device Lot Number: GLWL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2019
• Date Manufacturer Received: 01/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1