MAUDE Adverse Event Report: K2M. INC EVEREST SPINAL SYSTEM

Catalog Number 2901-10001

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 08/16/2018

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 planned extension surgery took place in which a set screw became loose approximately 4-6 months post-operatively 4 to 6 months post-operatively.A portion of the screw remains in the patient.Revision took place on (b)(6) 2018 (related to 3004774118-2018-00136).

Event Description

On (b)(6) 2018 it was reported to k2m, inc.That a planned extension surgery took place in which a set screw became lppse approximately 4-6 months post-operatively.A portion of the screw remains in the patient.Revision took place on 08.16.2018 ( related to 3004774118-00136).

Manufacturer Narrative

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 screw, it was observed that the screw displayed radial damage consistent with the effects of the reduction of the rod during tightening of the set screw.This can absorb the torque applied during the tightening phase, and allow for less than ideal locking forces.

• Brand Name: EVEREST SPINAL SYSTEM
• Type of Device: EVEREST SPINAL SYSTEM
• Manufacturer (Section D): K2M. INC; 600 hope parkway se; leesburg, va 20175
• MDR Report Key: 7908074
• MDR Text Key: 121710144
• Report Number: 3004774118-2018-00146
• 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: distributor
• Type of Report: Initial,Followup
• Report Date: 08/16/2018

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: 2901-10001
• Device Lot Number: GGCJ
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/04/2018
• Initial Date FDA Received: 09/25/2018
• Supplement Dates Manufacturer Received: 09/04/2018
• Supplement Dates FDA Received: 11/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 1001-E5550 LOT FNXK; 1001-E5550 LOT FNXK; E5112-06540 LOT GGXY; E5112-06540 LOT GGXY; E5112-07540 LOT EWGW; E5112-07540 LOT EWGW
• Patient Outcome(s): Required Intervention