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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: K2M, INC. MI OFFSET ROD REDUCER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
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K2M, INC. MI OFFSET ROD REDUCER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Back to Search Results
Model Number 5101-90012
Device Problems Material Deformation (2976); Failure to Eject (4010)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/11/2022
Event Type  malfunction  
Event Description
It was reported that the everest mi offset rod reducer was difficult to come off of the screw and was broken/bent when attempting to remove.The surgery was completed successfully with no surgical delay.No adverse consequences or medical intervention were reported.
 
Manufacturer Narrative
H6 coding has been updated to reflect investigation conclusion.H3 other text: no product returned.
 
Event Description
It was reported that the everest mi offset rod reducer was difficult to come off of the screw and was broken/bent when attempting to remove.The surgery was completed successfully with no surgical delay.No adverse consequences or medical intervention were reported.
 
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Brand Name
MI OFFSET ROD REDUCER
Type of Device
ORTHOPEDIC MANUAL SURGICAL 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 Key15185999
MDR Text Key300319281
Report Number3004774118-2022-00319
Device Sequence Number1
Product Code LXH
UDI-Device Identifier10888857104006
UDI-Public10888857104006
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 11/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/08/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number5101-90012
Device Catalogue Number5101-90012
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received10/07/2022
Was Device Evaluated by Manufacturer? No
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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