11.5" TITANIUM PECTUS BAR N/A PT-3137

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-11-30 for 11.5" TITANIUM PECTUS BAR N/A PT-3137 manufactured by Biomet Microfixation.

MAUDE Entry Details

Report Number0001032347-2019-00518
MDR Report Key9392280
Report SourceHEALTH PROFESSIONAL
Date Received2019-11-30
Date of Report2019-11-29
Date of Event2019-07-12
Date Mfgr Received2019-11-29
Device Manufacturer Date2019-07-03
Date Added to Maude2019-11-30
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. CHRISTOPHER PAPPAS
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 Name11.5" TITANIUM PECTUS BAR
Generic NameCUSTOM TITANIUM PECTUS BAR
Product CodeHRS
Date Received2019-11-30
Model NumberN/A
Catalog NumberPT-3137
Lot Number918430
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
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
10 2019-11-30

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