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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OTTO BOCK HEALTHCARE PRODUCTS GMBH C-LEG; EXTERNAL KNEE PROSTHETIC COMPONENT

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OTTO BOCK HEALTHCARE PRODUCTS GMBH C-LEG; EXTERNAL KNEE PROSTHETIC COMPONENT Back to Search Results
Model Number 3C98-3
Device Problem Unintended System Motion (1430)
Patient Problem Damage to Ligament(s) (1952)
Event Date 11/04/2022
Event Type  Injury  
Event Description
While walking the knee gave out; level walking; patient fell.Tore rotator cuff - necessitates med.Treatment.Noise - hissing / gurgling.Battery-/charging issue - battery charge does not last long.
 
Manufacturer Narrative
Device is currently not available for evaluation; supplemental report will be submitted after evaluation of all device components is completed.
 
Event Description
While walking the knee gave out; level walking; patient fell and tore rotator cuff - necessitates med.Treatment.Noise - hissing / gurgling.Battery-/charging issue - battery charge does not last long.Further information received on 12/07/2022:medical treatment: put in sling (outpatient treatment).
 
Manufacturer Narrative
Further information received on 12/07/2022: medical treatment: put in sling (outpatient treatment) which resulted in a lower extent of damage and correction of health effect code (h6).
 
Event Description
While walking the knee gave out; level walking; patient fell.Tore rotator cuff - necessitates med.Treatment.Noise - hissing / gurgling.Battery-/charging issue - battery charge does not last long.Further information received on 12/07/2022: medical treatment: put in sling (outpatient treatment).
 
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Brand Name
C-LEG
Type of Device
EXTERNAL KNEE PROSTHETIC COMPONENT
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 Key15931126
MDR Text Key304957888
Report Number9615892-2022-00019
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 Health Professional,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 11/10/2022
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? No
Device Operator Lay User/Patient
Device Model Number3C98-3
Device Catalogue Number3C98-3
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/10/2022
Initial Date FDA Received12/07/2022
Supplement Dates Manufacturer Received12/07/2022
06/14/2023
Supplement Dates FDA Received12/21/2022
06/15/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/03/2022
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
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