UNKNOWN_K2M_PRODUCT UNK_SPE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-14 for UNKNOWN_K2M_PRODUCT UNK_SPE manufactured by K2m, Inc..

Event Text Entries

[183769010] Return status of the device is unknown.
Patient Sequence No: 1, Text Type: N, H10


[183769011] Stryker representative reported that the placement of an unknown illiac screw was not 'optimal' post-operatively. Revision surgery has occurred.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004774118-2020-00029
MDR Report Key9832855
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-03-14
Date of Report2020-03-13
Date of Event2020-02-12
Date Mfgr Received2020-02-12
Date Added to Maude2020-03-14
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. RITA KARAN
Manufacturer Street2 PEARL COURT
Manufacturer CityALLENDALE NJ 07401
Manufacturer CountryUS
Manufacturer Postal07401
Manufacturer Phone2017608000
Manufacturer G1K2M, INC.
Manufacturer Street600 HOPE PARKWAY SE
Manufacturer CityLEESBURG VA 20175
Manufacturer CountryUS
Manufacturer Postal Code20175
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUNKNOWN_K2M_PRODUCT
Generic NameTHORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Product CodeMNI
Date Received2020-03-14
Catalog NumberUNK_SPE
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerK2M, INC.
Manufacturer Address600 HOPE PARKWAY SE LEESBURG VA 20175 US 20175


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-14

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