FITBONE TAA1180-T-245 60001348

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 2020-03-27 for FITBONE TAA1180-T-245 60001348 manufactured by Wittenstein Intens Gmbh.

Event Text Entries

[188261611] The event problem and evaluation codes were only chosen according to the surgeons event report. The codes will become more specific after investigation.
Patient Sequence No: 1, Text Type: N, H10


[188261612] Distraction of the tibia implant stopped. Pulses on the control set were initiated, but the audible response was absent. Radiologically the incomplete distraction was confirmed. According to the patient's wishes, the femoral implant is lengthened to 6 cm instead of 4 cm to compensate the undercorrection of the tibia.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3003236810-2020-00011
MDR Report Key9887779
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-27
Date of Report2020-03-27
Date of Event2020-02-21
Date Mfgr Received2020-02-21
Device Manufacturer Date2018-03-29
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 ActionIN
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFITBONE
Generic NameINTRAMEDULLARY LENGTHENING NAIL
Product CodeHSB
Date Received2020-03-27
Model NumberTAA1180-T-245
Catalog Number60001348
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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