ASCENSION MCP MCP-100 MCP-100-30P

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-08-07 for ASCENSION MCP MCP-100 MCP-100-30P manufactured by Ascension Orthopedics, Inc..

Event Text Entries

[894357] Surgeon removed fractured implant due to pain.
Patient Sequence No: 1, Text Type: D, B5


[8113045] Conclusions: fracture occurred in a rapid, brittle, bending mode. There were no indications of defects in the component. Stem fractures are known to occur surgically upon seating impact as a result of incomplete broaching of the medullary canal.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1651501-2008-00013
MDR Report Key1106843
Report Source05
Date Received2008-08-07
Date of Report2008-08-06
Date of Event2008-04-18
Date Mfgr Received2008-07-01
Date Added to Maude2009-06-03
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactLYNN FERGUSON
Manufacturer Street8700 CAMERON RD., STE. 100
Manufacturer CityAUSTIN TX 78754
Manufacturer CountryUS
Manufacturer Postal78754
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameASCENSION MCP
Generic NameTOTAL FINGER JOINT IMPLANT
Product CodeKWF
Date Received2008-08-07
Returned To Mfg2008-07-07
Model NumberMCP-100
Catalog NumberMCP-100-30P
Lot NumberUNK
ID NumberNA
OperatorLAY USER/PATIENT
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerASCENSION ORTHOPEDICS, INC.
Manufacturer Address8700 CAMERON RD., STE. 100 AUSTIN TX 78754 US 78754


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2008-08-07

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