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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: K2M, INC. AXIAL ROD CONNECTOR, OPEN-CLOSED; SIZE 5.5/6.0 - 5.5/6.0 THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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K2M, INC. AXIAL ROD CONNECTOR, OPEN-CLOSED; SIZE 5.5/6.0 - 5.5/6.0 THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 2901-86055MF
Device Problems Mechanical Jam (2983); Insufficient Information (3190)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/14/2020
Event Type  malfunction  
Event Description
A company representative reported that the set screw would not thread into two everest axial rod-to-rod connectors during product inspection. There is no procedure associated with this reported event, no patient involvement, and no adverse consequence has been reported. This report captures the second of the two devices.
 
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Brand NameAXIAL ROD CONNECTOR, OPEN-CLOSED; SIZE 5.5/6.0 - 5.5/6.0
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 Key10404895
MDR Text Key202956149
Report Number3004774118-2020-00182
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K143334
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 10/27/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number2901-86055MF
Device Catalogue Number2901-86055MF
Device Lot NumberEJVX
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/24/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/28/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/12/2020
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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