CARTIVA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-02 for CARTIVA manufactured by Cartiva, Inc / Wright Medical Group.

MAUDE Entry Details

Report NumberMW5088743
MDR Report Key8861207
Date Received2019-08-02
Date of Report2019-07-31
Date of Event2018-12-22
Date Added to Maude2019-08-05
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameCARTIVA
Generic NamePROSTHESIS, METATARSOPHALANGEAL JOINT, CARTILAGE REPLACEMENT IMPLANT
Product CodePNW
Date Received2019-08-02
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCARTIVA, INC / WRIGHT MEDICAL GROUP


Patients

Patient NumberTreatmentOutcomeDate
101. Deathisabilit 2019-08-02

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