GTS TRUNNION RASP S-2 N/A 110025196

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-09 for GTS TRUNNION RASP S-2 N/A 110025196 manufactured by Biomet France S.a.r.l..

MAUDE Entry Details

Report Number3006946279-2019-00361
MDR Report Key8878421
Date Received2019-08-09
Date of Report2019-08-07
Date of Event2019-07-17
Date Mfgr Received2019-07-17
Device Manufacturer Date2017-09-28
Date Added to Maude2019-08-09
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 ContactMS. CHRISTINA ARNT
Manufacturer Street56 E, BELL DR.
Manufacturer CityWARSAW IN 46582
Manufacturer CountryUS
Manufacturer Postal46582
Manufacturer Phone5745273773
Manufacturer G1BIOMET FRANCE S.A.R.L.
Manufacturer StreetPLATEAU DE LAUTAGNE BP75
Manufacturer CityVALENCE CEDEX 26903
Manufacturer CountryFR
Manufacturer Postal Code26903
Single Use3
Previous Use Code3
Removal Correction NumberN/A
Event Type3
Type of Report0

Device Details

Brand NameGTS TRUNNION RASP S-2
Generic NameORTHOPAEDIC PROSTHESIS IMPLANTATION INSTRUMENT, REUSABLE
Product CodeHTR
Date Received2019-08-09
Model NumberN/A
Catalog Number110025196
Lot Number369650
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBIOMET FRANCE S.A.R.L.
Manufacturer AddressPLATEAU DE LAUTAGNE BP75 VALENCE CEDEX 26903 FR 26903


Patients

Patient NumberTreatmentOutcomeDate
10 2019-08-09

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