MAUDE Adverse Event Report: K2M, INC. EVEREST PEDICLE SCREW SYSTEM; SET SCREW

Catalog Number 2911-06540

Device Problem Insufficient Information (3190)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 07/12/2014

Event Type  Injury  

Event Description

Everest screw and patient revised approximately two years post-op.Patient had a pseudoarthrosis.

Manufacturer Narrative

The patient reportedly did not fuse and the patient developed stenosis at the adjacent level.The original surgery l3-5 was performed on (b)(6) 2012.The fracture occurred some time ago but, the patient did well prior to developing stenosis at l1-2 &l3-4.The fractured 5.5x40 screw was removed, replaced with a 6.5x45 screw and the fusion was extended to include l1 & l2.The broken screw was retained by the hospital and will not be returning however, the manufacturing records were reviewed and no discrepancies were found.This report is being filed as a precaution as the incident is not believed to be related to the product.The root cause of the fracture is likely the pseudoarthrosis.These screws are intended to serve as an adjunct to fusion and in the absence of fusion 2 years post-operatively, a fracture of any of the screws is possible.Part retained by hospital.

• Brand Name: EVEREST PEDICLE SCREW SYSTEM
• Type of Device: SET SCREW
• Manufacturer (Section D): K2M, INC.; 751 miller drive se; leesburg VA 20175
• Manufacturer (Section G): K2M, INC.; 751 miller drive se; leesburg VA 20175
• Manufacturer Contact: rich woods ; 751 miller drive se; leesburg, VA 20175 ; 7037773155
• MDR Report Key: 3979182
• MDR Text Key: 4635207
• Report Number: 3004774118-2014-00030
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• PMA/PMN Number: K103440
• 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: 08/05/2014

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 Catalogue Number: 2911-06540
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/12/2014
• Initial Date FDA Received: 08/05/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2011
• 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