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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. VALOR(R) NAIL; SMALL JOINT COMPONENT
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WRIGHT MEDICAL TECHNOLOGY, INC. VALOR(R) NAIL; SMALL JOINT COMPONENT Back to Search Results
Catalog Number 415101020R
Device Problems Bent (1059); Fracture (1260); Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923); Material Deformation (2976)
Patient Problem No Information (3190)
Event Date 10/13/2014
Event Type  Injury  
Event Description
Allegedly during surgery, the nail bent on implantation, making targeting ineffectual.Tibia and ankle were deformed and not corrected by wire or reaming.Patient had previous tibial fracture and ankle dislocation fixed poorly.
 
Manufacturer Narrative
Investigation not complete.Product has not been returned.Trends will be evaluated.The event device code is addressed in the package insert.This report will be updated when the investigation is complete.
 
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Brand Name
VALOR(R) NAIL
Type of Device
SMALL JOINT COMPONENT
Manufacturer (Section D)
WRIGHT MEDICAL TECHNOLOGY, INC.
11576 memphis arlington rd
arlington TN 38002
Manufacturer (Section G)
WRIGHT MEDICAL TECHNOLOGY, INC.
11576 memphis arlington rd
arlington TN 38002
Manufacturer Contact
1023 cherry road
memphis, TN 38117
901867-414
MDR Report Key4260098
MDR Text Key20272828
Report Number1043534-2014-00170
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K090857
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 11/18/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Physician
Device Catalogue Number415101020R
Device Lot Number1101251578
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/04/2014
Initial Date FDA Received11/18/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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