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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMT AG / INTEGRATED MEDICAL TECHNOLOGIES WOODPECKER, TOTAL HIP BROACHING SYSTEM
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IMT AG / INTEGRATED MEDICAL TECHNOLOGIES WOODPECKER, TOTAL HIP BROACHING SYSTEM Back to Search Results
Model Number 929
Device Problem Defective Device (2588)
Patient Problem Hip Fracture (2349)
Event Date 01/10/2013
Event Type  Injury  
Event Description
"during a hip surgery, dr (b)(6) in (b)(6) hospital in (b)(6), he used a surgical device called woodpecker built in (b)(4) and broke my hip.The engineer expert that inspected the device said the reason is because it is a defect on the design and not properly maintained for malfunction.In the same hospital in the week of my surgery, and i found that another lady happened the same like me, same hospital, same doctor.How many we do not know.Remember they say the fda do not care so the hospital drs and the manufacture-company do not care because the fda do not take the time to investigate the question who us the pts are going to blame, the fda that do not do what they are supposed to do and allow to keep using this device.I think so is the fda fault as the largest country in the world the usa do not have a fda that after a complaint do not take actions until they get sue for it.The hospital has the device and inspected from a professor of one of the best university have the report.".
 
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Brand Name
WOODPECKER, TOTAL HIP BROACHING SYSTEM
Type of Device
WOODPECKER, TOTAL HIP BROACHING SYSTEM
Manufacturer (Section D)
IMT AG / INTEGRATED MEDICAL TECHNOLOGIES
MDR Report Key6785063
MDR Text Key82468745
Report NumberMW5071476
Device Sequence Number1
Product Code GET
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 08/08/2017
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 Health Professional
Device Model Number929
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/08/2017
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other; Disability;
Patient Weight79
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