FORESIGHT 71113008

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2005-04-07 for FORESIGHT 71113008 manufactured by Smith & Nephew, Inc., Orthopaedic Div..

Event Text Entries

[15006768] It was reported that surgical time was extended due to the device fractured.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1020279-2005-00155
MDR Report Key588851
Report Source07
Date Received2005-04-07
Date of Report2005-04-07
Date of Event2005-02-22
Date Mfgr Received2005-03-04
Device Manufacturer Date2001-08-01
Date Added to Maude2005-04-08
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. JASON CHAMNESS, SPECIALIST
Manufacturer Street1450 BROOKS ROAD
Manufacturer CityMEMPHIS TN 38116
Manufacturer CountryUS
Manufacturer Postal38116
Manufacturer Phone9013995899
Manufacturer G1SMITH & NEPHEW INC.
Manufacturer Street1450 BROOKS ROAD
Manufacturer CityMEMPHIS TN 38116
Manufacturer CountryUS
Manufacturer Postal Code38116
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFORESIGHT
Generic NameDRILL GUIDE BOLT
Product CodeHXY
Date Received2005-04-07
Returned To Mfg2005-03-21
Model NumberNA
Catalog Number71113008
Lot Number01HM05273
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Age20 MO
Device Eval'ed by MfgrN
Implant FlagY
Date RemovedV
Device Sequence No1
Device Event Key578690
ManufacturerSMITH & NEPHEW, INC., ORTHOPAEDIC DIV.
Manufacturer Address1450 BROOKS RD. MEMPHIS TN 38116 US
Baseline Brand NameFORESIGHT
Baseline Generic NameDRILL GUIDE BOLT
Baseline Model NoNA
Baseline Catalog No71113008
Baseline IDNA


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2005-04-07

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