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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE 5.5X45 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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K2M, INC. POLYAXIAL SCREW; SIZE 5.5X45 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 2911-05545
Device Problem Mechanical Problem (1384)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/21/2020
Event Type  malfunction  
Manufacturer Narrative
Devices remains implanted.
 
Event Description
It was reported that during intra-operative final tightening of an everest polyaxial screw at t5, the screw tulip 'splayed'.The screw was left inside the patient as is.There were no adverse consequences to the patient.The procedure was completed successfully with a 1-minute delay to surgery by leaving the screw in place.
 
Manufacturer Narrative
Visual, dimensional, functional and material analysis could not be performed as the device was not returned.A review of device and complaint history records could not be performed as a valid lot code was not provided and could not be obtained.Per email correspondence, tulip was not over angulated.Final tightening was performed using torque wrench and anti torque handle, excessive force was not applied.Due to device not returned, an exact cause of the reported event could not be determined.Causes related to this event include: excess torque applied while final tightening, torque wrench not calibrated, cantilever force applied, etc.
 
Event Description
It was reported that during intra-operative final tightening of an everest polyaxial screw at t5, the screw tulip 'splayed'.The screw was left inside the patient as is.There were no adverse consequences to the patient.The procedure was completed successfully with a 1-minute delay to surgery by leaving the screw in place.
 
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Brand Name
POLYAXIAL SCREW; SIZE 5.5X45 MM
Type of Device
THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
K2M, INC.
600 hope parkway se
leesburg VA 20175
MDR Report Key11023570
MDR Text Key226111255
Report Number3004774118-2020-00349
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10888857041912
UDI-Public10888857041912
Combination Product (y/n)N
PMA/PMN Number
K133944
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 03/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2911-05545
Device Catalogue Number2911-05545
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received02/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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