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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: K2M, INC. NAVIGATED CERVICAL SCREW INSERTER; YUKON®; ORTHOPEDIC STEREOTAXIC INSTRUMENT
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K2M, INC. NAVIGATED CERVICAL SCREW INSERTER; YUKON®; ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 7601-N90003-M
Device Problem Failure to Eject (4010)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/01/2022
Event Type  malfunction  
Event Description
This record is a consolidation of q3 2022 records summarized as a part of the fda voluntary malfunction summary reporting program.This report captures two instance of intraoperative yukon navigated screw inserter jamming in which the physician had difficulty dissociating the tip of the inserter from the screw after screw insertion.The associated procedure was completed successfully with no surgical delay and no adverse consequence to a patient.
 
Manufacturer Narrative
Lot mwch (2): device returned 21 september 2022.
 
Manufacturer Narrative
Lot mwch (2): manufacture date 29 january 2021, device returned 21 september 2022.
 
Event Description
This record is a consolidation of q3 2022 records summarized as a part of the fda voluntary malfunction summary reporting program.This report captures two instance of intraoperative yukon navigated screw inserter jamming in which the physician had difficulty dissociating the tip of the inserter from the screw after screw insertion.The associated procedure was completed successfully with no surgical delay and no adverse consequence to a patient.
 
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Brand Name
NAVIGATED CERVICAL SCREW INSERTER; YUKON®
Type of Device
ORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
K2M, INC.
600 hope parkway se
leesburg VA 20175
Manufacturer (Section G)
K2M, INC.
600 hope parkway se
leesburg VA 20175
Manufacturer Contact
rita karan
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key15700536
MDR Text Key303247817
Report Number3004774118-2022-00380
Device Sequence Number1
Product Code OLO
UDI-Device Identifier10888857415973
UDI-Public10888857415973
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K201006
Number of Events Reported2
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/19/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/31/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number7601-N90003-M
Device Catalogue Number7601-N90003-M
Device Lot NumberMWCH
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/21/2022
Is the Reporter a Health Professional? No
Date Manufacturer Received01/01/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/29/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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