ELEVATOR #301 N/A 09-0257

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-07-07 for ELEVATOR #301 N/A 09-0257 manufactured by Biomet Microfixation.

MAUDE Entry Details

Report Number0001032347-2019-00354
MDR Report Key8766120
Report SourceDISTRIBUTOR
Date Received2019-07-07
Date of Report2019-09-06
Date Mfgr Received2019-08-27
Device Manufacturer Date2011-11-11
Date Added to Maude2019-07-07
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. MERRIANNE CASSIDY
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 NameELEVATOR #301
Generic NameELEVATOR, SURGICAL, DENTAL
Product CodeEMJ
Date Received2019-07-07
Returned To Mfg2019-08-27
Model NumberN/A
Catalog Number09-0257
Lot Number111111K11
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBIOMET MICROFIXATION
Manufacturer Address1520 TRADEPORT DRIVE JACKSONVILLE FL 32218 US 32218


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-07-07

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