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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 Problem Migration or Expulsion of Device (1395)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/20/2022
Event Type  malfunction  
Manufacturer Narrative
Device remains implanted.
 
Event Description
A company representative reported an axial slip of a mesa deformity uniplanar screw. Revision surgery has not been scheduled.
 
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Brand NameDEFORMITY, UNIPLANAR SCREW; SIZE Ø6.5X45 MM
Type of DeviceTHORACOLUMBOSACRAL 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 Key14292337
MDR Text Key292725368
Report Number3004774118-2022-00177
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
Type of Report Initial,Followup
Report Date 08/15/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/05/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number801-36545M
Device Catalogue Number801-36545M
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/16/2022
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

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