MAUDE Adverse Event Report: K2M. INC, A SUBSIDIARY OF STRYKER CORPORATION EVEREST® SPINAL SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number F2911-06550

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 03/26/2018

Event Type  Injury  

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.The subject product has not been returned for evaluation yet.Investigation is still in process.When investigation is complete, k2m inc.Will file a supplemental report indicating the findings.

Event Description

On (b)(6) 2018 it was reported to k2m, inc.That a revision surgery took place due to a screw break afe approximately 7-9 months post-operatively.Patient was revised on (b)(6) 2018.

Event Description

On (b)(6) 2018 it was reported to k2m, inc that a surgery took place in which a fenestrated screw broke approximately nine months post-operatively.

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.The shaft of the screw was confirmed to be broken approximately 25 millimeters from the head assembly.The fracture face exhibits characteristics consistent with failure in fatigue.It is possible that a lack of supplemental fixation at adjacent levels allowed for a degree of dynamic motion within the construct, contributing to a failure in fatigue.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, A SUBSIDIARY OF STRYKER CORPORATION; 600 hope parkway se; leesburg, va 20175
• MDR Report Key: 8213725
• MDR Text Key: 132629924
• Report Number: 3004774118-2018-00189
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K151727
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 04/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: F2911-06550
• Device Lot Number: FTAY
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention