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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 Mechanical Jam (2983)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/10/2021
Event Type  malfunction  
Event Description
A company representative reported that a yukon navigated screw inserter tip was jamming during surgery and could not be disconnected from the screw.The surgery was completed successfully following an unspecified delay with no adverse consequence to the patient.
 
Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device and complaint history records review could not be performed as a valid lot code was not provided and could not be obtained.Since the device was not returned, an exact cause of the reported event could not be determined.Inserting the screw with more force than normal, on a bone, can compound torsional forces at the screw/inserter interface, compromising the insertion feature of the screw head.As mentioned in the product ifu, to fully seat the inserter into the screw-head, the inserter has to be completely aligned with the screw.Ensuring that the screw is securely engaged in the inserter tip can assist in distributing forces evenly throughout the screw/inserter interface, reduce torque overloading, and reduce failures as reported.
 
Event Description
A company representative reported that a yukon navigated screw inserter tip was jamming during surgery and could not be disconnected from the screw.The surgery was completed successfully following an unspecified delay with no adverse consequence to the 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
MDR Report Key11446072
MDR Text Key238676200
Report Number3004774118-2021-00069
Device Sequence Number1
Product Code OLO
UDI-Device Identifier10888857415973
UDI-Public10888857415973
Combination Product (y/n)N
PMA/PMN Number
K201006
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 06/29/2021
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 Number7601-N90003-M
Device Catalogue Number7601-N90003-M
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/10/2021
Initial Date FDA Received03/09/2021
Supplement Dates Manufacturer Received05/31/2021
Supplement Dates FDA Received06/29/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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