UNK BIOMET SCREW

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-11-14 for UNK BIOMET SCREW manufactured by Biomet 3i.

MAUDE Entry Details

Report Number0001038806-2019-01373
MDR Report Key9321490
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2019-11-14
Date of Report2019-11-14
Date of Event2019-09-30
Date Mfgr Received2019-10-15
Date Added to Maude2019-11-14
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationDENTIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS SUSANNE TAYLOR
Manufacturer Street4555 RIVERSIDE DRIVE
Manufacturer CityPALM BEACH GARDENS FL 33410
Manufacturer CountryUS
Manufacturer Postal33410
Manufacturer Phone5617766700
Manufacturer G1BIOMET 3I
Manufacturer Street4555 RIVERSIDE DRIVE
Manufacturer CityPALM BEACH GARDENS FL 33410
Manufacturer CountryUS
Manufacturer Postal Code33410
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Generic NameSCREW
Product CodeNHA
Date Received2019-11-14
Returned To Mfg2019-10-15
Catalog NumberUNK BIOMET SCREW
OperatorLAY USER/PATIENT
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerBIOMET 3I
Manufacturer Address4555 RIVERSIDE DRIVE PALM BEACH GARDENS FL 33410 US 33410


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-11-14

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