IJS IJS-E AXIS PIN 2.5MM X 50MM IJS-EAP-25500

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-07 for IJS IJS-E AXIS PIN 2.5MM X 50MM IJS-EAP-25500 manufactured by Skeletal Dynamics L.l.c..

MAUDE Entry Details

Report Number9161163
MDR Report Key9161163
Date Received2019-10-07
Date of Report2019-09-27
Date of Event2019-09-10
Report Date2019-09-27
Date Reported to FDA2019-09-27
Date Reported to Mfgr2019-10-07
Date Added to Maude2019-10-07
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
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
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameIJS
Generic NameINTERNAL HINGED ELBOW FIXATOR
Product CodeOZI
Date Received2019-10-07
Model NumberIJS-E AXIS PIN 2.5MM X 50MM
Catalog NumberIJS-EAP-25500
Device AvailabilityY
Device Age1 MO
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerSKELETAL DYNAMICS L.L.C.
Manufacturer Address7300 N KENDALL DRIVE SUITE 400 MIAMI FL 33156 US 33156


Patients

Patient NumberTreatmentOutcomeDate
10 2019-10-07

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