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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW, CLOSED; SIZE Ø8.5X70 MM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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K2M, INC. POLYAXIAL SCREW, CLOSED; SIZE Ø8.5X70 MM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 2901-08570G
Device Problems Fracture (1260); Migration or Expulsion of Device (1395); Material Separation (1562)
Patient Problem Insufficient Information (4580)
Event Date 01/12/2022
Event Type  Injury  
Event Description
It was reported that two everest polyaxial screws at s2 broke post-operatively. Additionally, the two everest set screws at s1 migrated as well as one at right l5. Revision surgery has been performed. This report captures the second fractured polyaxial screws.
 
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Brand NamePOLYAXIAL SCREW, CLOSED; SIZE Ø8.5X70 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 Key13502085
MDR Text Key285671943
Report Number3004774118-2022-00049
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10888857037625
UDI-Public10888857037625
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K140529
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/09/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2901-08570G
Device Catalogue Number2901-08570G
Device Lot NumberMUKG
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/31/2022
Is the Reporter a Health Professional? No
Date Manufacturer Received04/21/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/09/2022 Patient Sequence Number: 1
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