IMPLANT SYSTEM, MINI TIGHTROPE, 1.1 MM AR-8914DS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-03-26 for IMPLANT SYSTEM, MINI TIGHTROPE, 1.1 MM AR-8914DS manufactured by Arthrex, Inc..

MAUDE Entry Details

Report Number1220246-2020-01766
MDR Report Key9883007
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2020-03-26
Date of Report2020-03-26
Date of Event2020-03-03
Date Mfgr Received2020-03-04
Date Added to Maude2020-03-26
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 ContactVIK BAJNATH
Manufacturer Phone8009337001
Manufacturer G1ARTHREX, INC.
Manufacturer Street1370 CREEKSIDE BOULEVARD
Manufacturer CityNAPLES FL 341081945
Manufacturer CountryUS
Manufacturer Postal Code341081945
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameIMPLANT SYSTEM, MINI TIGHTROPE, 1.1 MM
Generic NameWASHER, BOLT NUT
Product CodeHTN
Date Received2020-03-26
Model NumberIMPLANT SYSTEM, MINI TIGHTROPE, 1.1 MM
Catalog NumberAR-8914DS
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerARTHREX, INC.
Manufacturer Address1370 CREEKSIDE BOULEVARD NAPLES FL 341081945 US 341081945


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-26

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