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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: K2M, INC. SET SCREW; ATR THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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K2M, INC. SET SCREW; ATR THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 2901-10001
Device Problem Migration (4003)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/20/2022
Event Type  malfunction  
Manufacturer Narrative
Device remains implanted.
 
Event Description
It was reported via x-ray that two (2) everest sacroiliac screws showed apparent back out and disengagement post-operatively. The x-ray provided also shows migration of two (2) associated everest set screws. Revision surgery has not been performed or scheduled at this time. This report captures the first of the two everest set screws.
 
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Brand NameSET SCREW; ATR
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 Key15258516
MDR Text Key298215544
Report Number3004774118-2022-00326
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10888857037939
UDI-Public10888857037939
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K143334
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial
Report Date 08/19/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/19/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2901-10001
Device Catalogue Number2901-10001
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/20/2022
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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