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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: K2M, INC. LOCKING SCREW INSERTER; EVEREST; ORTHOPEDIC STEREOTAXIC INSTRUMENT
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K2M, INC. LOCKING SCREW INSERTER; EVEREST; ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 2901-N90098-B
Device Problem Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2023
Event Type  malfunction  
Manufacturer Narrative
Lot jcvx (1): manufacture date 11 april 2019.Device returned 17 november 2022.
 
Event Description
This record is a consolidation of q4 2022 records summarized as a part of the fda voluntary malfunction summary reporting program.This report captures one instance of intraoperative everest locking screw inserter tip deformation.
 
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Brand Name
LOCKING SCREW INSERTER; EVEREST
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 Key16264994
MDR Text Key309139378
Report Number3004774118-2023-00008
Device Sequence Number1
Product Code OLO
UDI-Device Identifier10888857405486
UDI-Public10888857405486
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K181890
Number of Events Reported1
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 01/30/2023
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 Number2901-N90098-B
Device Catalogue Number2901-N90098-B
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/17/2022
Initial Date Manufacturer Received 01/01/2023
Initial Date FDA Received01/30/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/11/2019
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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