128040

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 2009-05-11 for 128040 manufactured by Brooks Manufacturing Site.

Event Text Entries

[1201949] It was reported that the k-wire bent approximately 6 weeks after the initial surgery, and that a revision surgery was required to correct.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1020279-2009-00562
MDR Report Key1379344
Report Source07
Date Received2009-05-11
Date of Report2009-05-08
Date of Event2009-05-05
Date Mfgr Received2009-05-08
Device Manufacturer Date2008-04-01
Date Added to Maude2009-05-14
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 FDA0
Event Location0
Manufacturer ContactMR. JERRY HOWARD
Manufacturer Street1450 BROOKS RD
Manufacturer CityMEMPHIS TN 38116
Manufacturer CountryUS
Manufacturer Postal38116
Manufacturer Phone9013996153
Manufacturer G1BROOKS MANUFACTURING SITE
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

Generic NameK-WIRE / DZK
Product CodeDZK
Date Received2009-05-11
Catalog Number128040
Lot Number08DM10187
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBROOKS MANUFACTURING SITE
Manufacturer AddressMEMPHIS TN US


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2009-05-11

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