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. FIXED ANGLE BONE SCREW DIAM 4.0 X 14MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
  • 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. FIXED ANGLE BONE SCREW DIAM 4.0 X 14MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY Back to Search Results
Model Number 48674014
Device Problems Material Deformation (2976); Migration (4003)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/02/2020
Event Type  malfunction  
Event Description
It was reported that there was a 'little damage' to the head of a reflex hybrid fixed angle bone screw which caused the screw to pass through the plate intra-operatively.Surgery was successfully completed with another screw and a 30 minute surgical delay.No adverse consequences or medical intervention were reported.
 
Event Description
It was reported that there was a 'little damage' to the head of a reflex hybrid fixed angle bone screw which caused the screw to pass through the plate intra-operatively.Surgery was successfully completed with another screw and a 30 minute surgical delay.No adverse consequences or medical intervention were reported.
 
Manufacturer Narrative
Visual inspection: the rib on the top of the screw was damaged and deformed, most likely from being driven through the locking ring on the plate.Device and complaint history records were reviewed, and no relevant manufacturing issues or similar complaints were identified.From the surgical technique: the amount of torque required to complete final tightening can be done with a single hand, and should not exceed one quarter turn once the screw is underneath the ring.In addition to the tactile sensation of the locking ring closing over the bone screw head, final screw locking should also be confirmed visually with the ring being clearly visible over the bone screw head.It is unknown how many turns were applied after the locking ring became visible.The damage on the screw is consistent with being driven below the locking ring.Most likely root cause is excessive torque or too many turns applied to the screw once the locking ring became visible.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
FIXED ANGLE BONE SCREW DIAM 4.0 X 14MM
Type of Device
APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Manufacturer (Section D)
K2M, INC.
600 hope parkway se
leesburg VA 20175
MDR Report Key10382248
MDR Text Key202224498
Report Number0009617544-2020-00134
Device Sequence Number1
Product Code KWQ
UDI-Device Identifier04546540392954
UDI-Public04546540392954
Combination Product (y/n)N
PMA/PMN Number
K040261
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 10/27/2020
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 Number48674014
Device Catalogue Number48674014
Device Lot Number3WP
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/31/2020
Initial Date Manufacturer Received 07/08/2020
Initial Date FDA Received08/07/2020
Supplement Dates Manufacturer Received09/30/2020
Supplement Dates FDA Received10/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-