Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW, CLOSED; SIZE 8.5X90 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

K2M, INC. POLYAXIAL SCREW, CLOSED; SIZE 8.5X90 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 2901-08590G
Device Problems Fracture (1260); Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/20/2020
Event Type  malfunction  
Event Description
Physician reported that two everest spinal system polyaxial screws, closed; size ø7.5x80 mm and closed; size ø8.5x90 mm, "broke" during revision surgery.Surgery was successfully completed with a 20 minute delay.No adverse consequences or medical intervention were reported.This report captures the second of two screws.
 
Manufacturer Narrative
D.4.Lot has been updated with received lot number.
 
Event Description
Physician reported that two everest spinal system polyaxial screws "broke" during revision surgery.Surgery was successfully completed with a 20 minute delay.No adverse consequences or medical intervention were reported.This report captures the second of two screws.
 
Manufacturer Narrative
Visual inspection: it was observed that the polyaxial screw tulip was disengaged from the screw shank.Device and complaint history records were reviewed, and no relevant manufacturing issues or similar complaints were identified.Everest implants are designed for use with everest surgical instruments.The everest implants comply with the standards applicable to the everest material composition.Using a non-stryker driver with the everest polyaxial screw is contraindicated in the product labeling.Other contributing factors may be using excess torque as well as reversing and taking out the screw to adjust.The root cause of the screw fracture is determined to be contraindicated usage of a non-stryker instrument during surgery.
 
Event Description
Physician reported that two everest spinal system polyaxial screws "broke" during revision surgery.Surgery was successfully completed with a 20 minute delay.No adverse consequences or medical intervention were reported.Upon inspection of the returned device, the screw tulip was disengaged from the screw shank.This report captures the second of two screws.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
POLYAXIAL SCREW, CLOSED; SIZE 8.5X90 MM
Type of Device
THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
K2M, INC.
600 hope parkway se
leesburg VA 20175
MDR Report Key10077570
MDR Text Key191698699
Report Number3004774118-2020-00095
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10888857037700
UDI-Public10888857037700
Combination Product (y/n)N
PMA/PMN Number
K140529
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup,Followup
Report Date 08/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2901-08590G
Device Catalogue Number2901-08590G
Device Lot NumberEAYU
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/17/2020
Initial Date Manufacturer Received 04/20/2020
Initial Date FDA Received05/20/2020
Supplement Dates Manufacturer Received06/17/2020
07/25/2020
Supplement Dates FDA Received07/15/2020
08/21/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-