FITBONE TAA1160-T-225 60001445

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-27 for FITBONE TAA1160-T-225 60001445 manufactured by Wittenstein Intens Gmbh.

MAUDE Entry Details

Report Number3003236810-2020-00006
MDR Report Key9887701
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2020-03-27
Date of Report2020-03-27
Date of Event2001-03-18
Device Manufacturer Date2018-04-18
Date Added to Maude2020-03-27
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. EVA LUNZ
Manufacturer StreetWALTER-WITTENSTEIN-STR. 1
Manufacturer CityIGERSHEIM, BADEN-WUERTTEMBERG 97999
Manufacturer CountryGM
Manufacturer Postal97999
Single Use3
Remedial ActionRL
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFITBONE
Generic NameINTRAMEDULLARY LENGTHENING NAIL
Product CodeHSB
Date Received2020-03-27
Model NumberTAA1160-T-225
Catalog Number60001445
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerWITTENSTEIN INTENS GMBH
Manufacturer AddressWALTER-WITTENSTEIN-STR. 1 IGERSHEIM, 97999 GM 97999


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-27

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