MAUDE Adverse Event Report: K2M. INC EVEREST ®SPINAL SYSTEM; ORTHOSIS SPINAL PEDICLE FIXATION

Catalog Number 2911-06540

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 11/16/2018

Event Type  Injury  

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) 2018 it was reported to k2m, inc that a screw broke 48 months post-op.The tulip head of the screw was successfully removed with remainder of the shaft being left within the pedicle.

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.The instrument was returned, visually and functionally inspected.Upon review of the part, it was observed that head was sheared from the shaft, which remains in the patient.Analysis of the shear face reveals striations in a raised and shiny surface.This is consistent with the effects of sudden stress fracture from point overloading at the event site.

Event Description

On (b)(6) 2018 it was reported to k2m, inc.That a screw broke 48 months post-operatively.The tulip head of the screw was successfully removed with remainder of the shaft being left within the pedicle.

• Brand Name: EVEREST ®SPINAL SYSTEM
• Type of Device: ORTHOSIS SPINAL PEDICLE FIXATION
• Manufacturer (Section D): K2M. INC; 600 hope parkway se; leesburg, va 20175
• MDR Report Key: 8162391
• MDR Text Key: 130313227
• Report Number: 3004774118-2018-00182
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• PMA/PMN Number: K133944
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 11/27/2018

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: Health Professional
• Device Catalogue Number: 2911-06540
• Device Lot Number: BKGX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2018
• Initial Date Manufacturer Received: 11/27/2018
• Initial Date FDA Received: 12/13/2018
• Supplement Dates Manufacturer Received: 11/27/2018
• Supplement Dates FDA Received: 02/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention