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

Catalog Number 2911-06540

Device Problems Break (1069); Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 10/01/2018

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 two broken screws approximately 2 years post-operatively.The patient was revised on (b)(6) 2018.

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.The subject product was returned for evaluation, and a thorough investigation was completed.Upon review of the parts, it was observed that the screws had sheared immediately distal to the screw neck.Analysis of the shear faces revealed a smooth and shiny surface, which is consistent with the effects of sudden brittle fracture.Compounding forces at the event site may have contributed to the cantilever forces already present at the distal end of the construct.

Event Description

On (b)(6) 2018 it was repord to k2m, inc.That a revision took place due to two broken screws approximately 2 years post-operatively.The patient was revised on (b)(6) 2018.

• Brand Name: EVEREST SPINAL SYSTEM
• Type of Device: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): K2M. INC; 600 hope parkway se; leesburg, va 20175
• MDR Report Key: 8031140
• MDR Text Key: 125903297
• Report Number: 3004774118-2018-00169
• 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: other
• Type of Report: Initial,Followup
• Report Date: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2018
• 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: DUDM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2018
• Date Manufacturer Received: 10/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention