CARTIVA SCI CAR-10-US

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2020-03-23 for CARTIVA SCI CAR-10-US manufactured by Cartiva, Inc.

Event Text Entries

[188208008] Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.
Patient Sequence No: 1, Text Type: N, H10


[188208009] It was reported that the patient underwent a surgical procedure on her foot. After over a year post-op the foot had not healed. During a visit with the surgeon, the patient was told that the implant had worn out and the patient had additional bone loss. The patient underwent a revision surgery to have her toe fused.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1043534-2020-00056
MDR Report Key9869433
Report SourceHEALTH PROFESSIONAL,OTHER
Date Received2020-03-23
Date of Report2020-02-24
Date of Event2020-01-29
Date Mfgr Received2020-02-24
Date Added to Maude2020-03-23
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 ContactMR MATTHEW PARRISH
Manufacturer Street1023 CHERRY RD
Manufacturer CityMEMPHIS TN 38117
Manufacturer CountryUS
Manufacturer Postal38117
Manufacturer G1CARTIVA, INC
Manufacturer Street6120 WINDWARD PARKWAY SUITE 220
Manufacturer CityALPHARETTA GA 30005
Manufacturer CountryUS
Manufacturer Postal Code30005
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCARTIVA SCI
Generic NamePROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT
Product CodePNW
Date Received2020-03-23
Model NumberCAR-10-US
Lot NumberF121417001
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCARTIVA, INC
Manufacturer Address6120 WINDWARD PARKWAY SUITE 220 ALPHARETTA GA 30005 US 30005


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-23

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