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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: K2M, INC. DEFORMITY, UNIPLANAR SCREW; SIZE Ø6.5X45 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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K2M, INC. DEFORMITY, UNIPLANAR SCREW; SIZE Ø6.5X45 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 801-36545M
Device Problems Material Separation (1562); Detachment of Device or Device Component (2907); Migration (4003)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/11/2022
Event Type  Injury  
Event Description
A physician reported axial slippage at the distal end of a construct on both the right and left-side.The left-side l3 mesa deformity uniplanar screw shaft additionally appears to be either fractured or disengaged from the tulip.The patient is being revised to address the axial slippage.This report captures the left-side mesa deformity uniplanar screw.
 
Manufacturer Narrative
H6 coding has been updated to reflect completion of the investigation.H3 other text : device not returned.
 
Event Description
A physician reported axial slippage at the distal end of a construct on both the right and left-side.The left-side l3 mesa deformity uniplanar screw shaft additionally appears to be either fractured or disengaged from the tulip.The patient is being revised to address the axial slippage.This report captures the left-side mesa deformity uniplanar screw.
 
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Brand Name
DEFORMITY, UNIPLANAR SCREW; SIZE Ø6.5X45 MM
Type of Device
THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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 Key15108466
MDR Text Key296657295
Report Number3004774118-2022-00285
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10888857140301
UDI-Public10888857140301
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K141873
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician Assistant
Type of Report Initial,Followup
Report Date 11/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Model Number801-36545M
Device Catalogue Number801-36545M
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/11/2022
Initial Date FDA Received07/26/2022
Supplement Dates Manufacturer Received10/07/2022
Supplement Dates FDA Received11/04/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age18 YR
Patient SexFemale
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