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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: K2M, INC. UNKNOWN_K2M_PRODUCT THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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K2M, INC. UNKNOWN_K2M_PRODUCT THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Catalog Number UNK_SPE
Device Problems Fracture (1260); Improper or Incorrect Procedure or Method (2017)
Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)
Event Date 09/03/2019
Event Type  malfunction  
Manufacturer Narrative
Device remains implanted in patient.
 
Event Description
A physician reported that the tab of an everest polyaxial screw, extended tab fenestrated, ø8. 5x80 mm, was "left in a patient by mistake. " a post- operative x-ray was performed a week after implantation and the tab, "was now visible. " revision surgery is planned but not yet scheduled.
 
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Brand NameUNKNOWN_K2M_PRODUCT
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 Key9384409
MDR Text Key168463091
Report Number3004774118-2019-00155
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K151727
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 03/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/27/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK_SPE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/29/2020
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 Treatment Data
Date Received: 11/27/2019 Patient Sequence Number: 1
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