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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: K2M, INC. HEIGHT EXPANSION DRIVER; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
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K2M, INC. HEIGHT EXPANSION DRIVER; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE Back to Search Results
Model Number 2112-90007
Device Problem Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/29/2021
Event Type  malfunction  
Event Description
It was reported that a capri expandable height expansion driver "no longer grips the screw head" after cleaning/sterilization.There is no procedure associated with this reported event, no patient involvement, and no adverse consequence has been reported.
 
Event Description
It was reported that a capri expandable height expansion driver "no longer grips the screw head" after cleaning/sterilization.There is no procedure associated with this reported event, no patient involvement, and no adverse consequence has been reported.
 
Manufacturer Narrative
Visual inspection: the tip of the driver was deformed and stripped.Device history records were reviewed for this lot and no relevant manufacturing issues were identified.Complaint history records were reviewed for this lot, similar complaints were identified.From the capri surgical technique guide: the life of the instrument depends on the number of times they are used as well as the precautions taken in handling, cleaning and storage.Great care must be taken of the instruments to ensure that they remain in good working order.Instruments should be examined for wear or damage by doctors and staff in operating centers prior to surgery as the device is five years old, wear from its extended use is the likely cause for the event.Misalignment with the mating screw and/or excessive force applied may also cause the tip to deform.
 
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Brand Name
HEIGHT EXPANSION DRIVER
Type of Device
SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
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 Key12987746
MDR Text Key288099866
Report Number3004774118-2021-00390
Device Sequence Number1
Product Code MPQ
UDI-Device Identifier10888857033641
UDI-Public10888857033641
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K142016
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 04/01/2022
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 Number2112-90007
Device Catalogue Number2112-90007
Device Lot NumberELDG
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/29/2021
Initial Date FDA Received12/13/2021
Supplement Dates Manufacturer Received03/04/2022
Supplement Dates FDA Received04/01/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/06/2016
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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