UNK DEPUY ANKLE SCREW

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2009-06-16 for UNK DEPUY ANKLE SCREW manufactured by Depuy Orthopaedics, Inc..

Event Text Entries

[1090937] The patient was revised because the screw was too long.
Patient Sequence No: 1, Text Type: D, B5


[8431869] Examination was not possible, as the product was not returned. The investigation was limited to review of the information provided, as the part and lot number required to review the device history records was not provided. Provided information states the patient was revised because a screw was too long. Based on the investigation, the need for corrective action is not indicated. Depuy considers the investigation closed. Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1818910-2009-03240
MDR Report Key1403905
Report Source05,07
Date Received2009-06-16
Date of Report2009-05-27
Date of Event2009-05-27
Date Mfgr Received2009-05-27
Date Added to Maude2009-06-23
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 ContactKATHERINE SEPPA, MGR
Manufacturer Street700 ORTHOPAEDIC DR.
Manufacturer CityWARSAW IN 465810988
Manufacturer CountryUS
Manufacturer Postal465810988
Manufacturer Phone5743727333
Manufacturer G1DEPUY ORTHOPAEDICS, INC.
Manufacturer Street700 ORTHOPAEDIC DR.
Manufacturer CityWARSAW IN 46581098
Manufacturer CountryUS
Manufacturer Postal Code46581 0988
Single Use3
Remedial ActionOT
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameUNK DEPUY ANKLE SCREW
Generic NameTOTAL ANKLE PROSTHESIS
Product CodeKXC
Date Received2009-06-16
Model NumberNA
Catalog NumberUNK
Lot NumberUNK
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDEPUY ORTHOPAEDICS, INC.
Manufacturer Address700 ORTHOPAEDIC DR. WARSAW IN 46581098 US 46581 0988


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2009-06-16

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