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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OTTO BOCK HEALTHCARE LP OTTO BOCK AXTION® PROSTHETIC FOOT; 1E56 AXTION® PROSTHETIC FOOT
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OTTO BOCK HEALTHCARE LP OTTO BOCK AXTION® PROSTHETIC FOOT; 1E56 AXTION® PROSTHETIC FOOT Back to Search Results
Model Number 1E56
Device Problem Fracture (1260)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/14/2017
Event Type  malfunction  
Event Description
The end-user was using the axtion foot during normal gardening activities when the pyramid adapter snapped in half.No fall or injury occurred as a result of the device failure.The end-user's foot was within the warranty period and the foot was being used as intended by the manufacturer.Out of an abundance of caution, this complaint will be reported as an mdr since this confirmed device failure is known to have the potential to cause serious injury.
 
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Brand Name
OTTO BOCK AXTION® PROSTHETIC FOOT
Type of Device
1E56 AXTION® PROSTHETIC FOOT
Manufacturer (Section D)
OTTO BOCK HEALTHCARE LP
3820 west great lakes drive
west valley city UT 84120
Manufacturer (Section G)
OTTO BOCK HEALTHCARE LP
3820 west great lakes drive
west valley city UT 84120
Manufacturer Contact
stephen anderson
3820 west great lakes drive
west valley city, UT 84120
8019746676
MDR Report Key7101800
MDR Text Key95742987
Report Number1721652-2017-00006
Device Sequence Number1
Product Code ISH
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Remedial Action Replace
Type of Report Initial
Report Date 12/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/08/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number1E56
Device Catalogue Number1E56=N27-5-P/0
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/04/2017
Date Manufacturer Received12/04/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/18/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Weight110
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