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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OTTO BOCK HEALTHCARE PRODUCTS GMBH C-LEG; EXTERNAL ABOVE KNEE PROSTHESIS
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OTTO BOCK HEALTHCARE PRODUCTS GMBH C-LEG; EXTERNAL ABOVE KNEE PROSTHESIS Back to Search Results
Model Number 3C98-3
Device Problem Device Handling Problem (3265)
Patient Problems Fall (1848); Bone Fracture(s) (1870)
Event Date 07/27/2020
Event Type  Injury  
Manufacturer Narrative
Device evaluation in progress; supplemental report will be submitted after additional information has been obtained.
 
Event Description
Patient fell - the exact course of action will follow, as the user is not yet responsive after surgery.After the 48-month service was made then complained and again patient tried the prosthesis and found out the next day that although the settings were absolutely the same, she had the feeling: the forefoot is too soft (exact description follows).
 
Manufacturer Narrative
Evaluation and investigation of the device showed no relevant error which may have caused or contributed to the occurred event.The event was caused by a wrong fitting of the prosthesis caused by the prosthetist - provided foot not accurate for user or mounted inaccurately.
 
Event Description
Patient fell - the exact course of action will follow, as the user is not yet responsive after surgery.After the 48-month service was made then complained and again patient tried the prosthesis and found out the next day that although the settings were absolutely the same, she had the feeling: the forefoot is too soft (exact description follows).July 23rd, july 26th in the morning · beating in the calf / heel.Less than before, but still present and uncomfortable.· toe too soft.Very present even on very slight inclines.Gives less security in the knee.You constantly have to keep your muscles under tension.· toe too soft / gives way too much on grass (soft ground).Noticeable with small bumps, joint / foot comes back in slow motion or does not react or freezes briefly and remains stiff.· calf / heel hits even more on paths with cobblestones.· the entire footrest was within the normal range.In the straight line from july 26th in the afternoon.· identical problems as described above.· in the afternoon the heel area had sunk.As if the entire forefoot was floating in the air.
 
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Brand Name
C-LEG
Type of Device
EXTERNAL ABOVE KNEE PROSTHESIS
Manufacturer (Section D)
OTTO BOCK HEALTHCARE PRODUCTS GMBH
brehmstrasse 16
vienna, aut 1110
AU  1110
MDR Report Key10390017
MDR Text Key202364534
Report Number9615892-2020-00007
Device Sequence Number1
Product Code ISY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Type of Report Initial,Followup
Report Date 07/27/2020
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? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number3C98-3
Device Catalogue Number3C98-3
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/06/2020
Date Manufacturer Received08/18/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age51 YR
Patient Weight56
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