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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OTTO BOCK HEALTHCARE PRODUCTS GMBH C-LEG KNEE JOINT; EXTERNAL ABOVE KNEE PROSTHESIS
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OTTO BOCK HEALTHCARE PRODUCTS GMBH C-LEG KNEE JOINT; EXTERNAL ABOVE KNEE PROSTHESIS Back to Search Results
Model Number 3C98-2=S
Device Problem Device Handling Problem (3265)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/01/2020
Event Type  malfunction  
Manufacturer Narrative
According to the event description no fall or injuries were mentioned.A soldering defect at the tube adapters strain gauge was detected which led to erroneous sensor signals and caused the occurred event.
 
Event Description
Incorrect behavior: stance phase resistance is too low.Pt said the c-leg is going into free swing and it will not hold the charger.
 
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Brand Name
C-LEG KNEE JOINT
Type of Device
EXTERNAL ABOVE KNEE PROSTHESIS
Manufacturer (Section D)
OTTO BOCK HEALTHCARE PRODUCTS GMBH
brehmstrasse 16
vienna, vienna 1110
AU  1110
Manufacturer Contact
reinhard wolkerstorfer
brehmstrasse 16
vienna, vienna 1110
AU   1110
MDR Report Key10389613
MDR Text Key217457045
Report Number9615892-2020-00008
Device Sequence Number1
Product Code ISY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/11/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number3C98-2=S
Device Catalogue Number3C98-2=S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/26/2020
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/16/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/19/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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