CARTIVA SCI

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-22 for CARTIVA SCI manufactured by Cartiva, Inc..

Event Text Entries

[146104482] On (b)(6) 2018, i had a cartiva implant on my toe. The pain is progressively getting worse since i had the surgery. It's hard for me to walk or exercise. I have gained weight. I was told my surgery was a failure by my dr. I am refusing to have another surgery at this time, i can't afford to take time off from work or another surgery. The dr told me i would be considered a success because i'm not getting another surgery. This is misleading and very disappointing that the fda would back this product. It should be removed from the market. I have developed pain in my knee and hip being that i am trying to keep weight off my big toe when i walk. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5086840
MDR Report Key8636148
Date Received2019-05-22
Date of Report2019-05-20
Date Added to Maude2019-05-23
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 SCI
Generic NamePROSTHESIS, METATARSUPHALANGEAL JOINT, CARTILAGE REPLACEMENT IMPLANT
Product CodePNW
Date Received2019-05-22
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerCARTIVA, INC.


Patients

Patient NumberTreatmentOutcomeDate
101. Deathisabilit 2019-05-22

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