UNKNOWN_K2M_PRODUCT UNK_SPE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-03 for UNKNOWN_K2M_PRODUCT UNK_SPE manufactured by Stryker Spine-leesburg.

MAUDE Entry Details

Report Number3004774118-2019-00113
MDR Report Key9153157
Date Received2019-10-03
Date of Report2019-10-03
Date of Event2019-02-21
Date Mfgr Received2019-05-21
Date Added to Maude2019-10-03
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. MARGARITA KARAN
Manufacturer Street2 PEARL COURT
Manufacturer CityALLENDALE NJ 07401
Manufacturer CountryUS
Manufacturer Postal07401
Manufacturer Phone2017608000
Manufacturer G1STRYKER SPINE-LEESBURG
Manufacturer Street600 HOPE PARKWAY SE
Manufacturer CityLEESBURG VA 20175
Manufacturer CountryUS
Manufacturer Postal Code20175
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameUNKNOWN_K2M_PRODUCT
Generic NameSPINAL VERTEBRAL BODY REPLACEMENT DEVICE
Product CodeMQP
Date Received2019-10-03
Catalog NumberUNK_SPE
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER SPINE-LEESBURG
Manufacturer Address600 HOPE PARKWAY SE LEESBURG VA 20175 US 20175


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-10-03

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