1.5MM SYSTEM LEFORT PLATE, FLAT 0.6MM N/A 01-6480

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2020-02-19 for 1.5MM SYSTEM LEFORT PLATE, FLAT 0.6MM N/A 01-6480 manufactured by Biomet Microfixation.

MAUDE Entry Details

Report Number0001032347-2020-00118
MDR Report Key9726900
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2020-02-19
Date of Report2020-03-11
Date of Event2020-01-16
Date Mfgr Received2020-02-18
Date Added to Maude2020-02-19
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 ContactMRS. JENNIFER DELANEY
Manufacturer Street1520 TRADEPORT DRIVE
Manufacturer CityJACKSONVILLE FL 32218
Manufacturer CountryUS
Manufacturer Postal32218
Manufacturer Phone9047414400
Manufacturer G1BIOMET MICROFIXATION
Manufacturer Street1520 TRADEPORT DRIVE
Manufacturer CityJACKSONVILLE FL 32218
Manufacturer CountryUS
Manufacturer Postal Code32218
Single Use3
Previous Use Code3
Removal Correction NumberN/A
Event Type3
Type of Report3

Device Details

Brand Name1.5MM SYSTEM LEFORT PLATE, FLAT 0.6MM
Generic NamePLATE, BONE
Product CodeJEY
Date Received2020-02-19
Returned To Mfg2020-02-24
Model NumberN/A
Catalog Number01-6480
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIOMET MICROFIXATION
Manufacturer Address1520 TRADEPORT DRIVE JACKSONVILLE FL 32218 US 32218


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2020-02-19

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