HTR-PMI K.S.2002-20191111 TOP RIGHT PARIETAL IMPLANT N/A PM622790

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 2020-02-10 for HTR-PMI K.S.2002-20191111 TOP RIGHT PARIETAL IMPLANT N/A PM622790 manufactured by Biomet Microfixation.

MAUDE Entry Details

Report Number0001032347-2020-00099
MDR Report Key9689588
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2020-02-10
Date of Report2020-02-10
Date Mfgr Received2020-01-29
Device Manufacturer Date2020-01-02
Date Added to Maude2020-02-10
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 NameHTR-PMI K.S.2002-20191111 TOP RIGHT PARIETAL IMPLANT
Generic NameCUSTOM MADE DEVICE
Product CodeGXN
Date Received2020-02-10
Model NumberN/A
Catalog NumberPM622790
Lot Number957180
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 2020-02-10

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