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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OTTO BOCK HEALTHCARE PRODUCTS GMBH EXTERNAL ABOVE KNEE PROSTHESIS; GENIUM X3 - BIONIC PROSTHETIC SYSTEM
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OTTO BOCK HEALTHCARE PRODUCTS GMBH EXTERNAL ABOVE KNEE PROSTHESIS; GENIUM X3 - BIONIC PROSTHETIC SYSTEM Back to Search Results
Model Number 3B5-X3=S
Device Problem Device Handling Problem (3265)
Patient Problems Fall (1848); Fracture, Arm (2351)
Event Date 10/30/2018
Event Type  Injury  
Manufacturer Narrative
Device is currently not available for evaluation (not returned from the customer yet); supplemental report will be submitted after evaluation of all device components is completed.
 
Event Description
The patients device was sent back to the manufacturer for service on 2018-10-17.Since receiving the new loaner unit the patient has had a fall and reported that he feels the x3 has given way when he steps backwards.This has happened 3 or 4 times.The technician has checked the alignment and the settings on the genium and cannot see any issues.The patient was apparently moving an empty box from a height and stepped backwards.
 
Manufacturer Narrative
Evaluation and investigation of the device showed no relevant error which may have caused or contributed to the occurred event.
 
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Brand Name
EXTERNAL ABOVE KNEE PROSTHESIS
Type of Device
GENIUM X3 - BIONIC PROSTHETIC SYSTEM
Manufacturer (Section D)
OTTO BOCK HEALTHCARE PRODUCTS GMBH
brehmstrasse 16
vienna, 1110
AU  1110
MDR Report Key8073512
MDR Text Key127236006
Report Number9615892-2018-00029
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 02/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number3B5-X3=S
Device Catalogue Number3B5-X3=S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/17/2018
Date Manufacturer Received01/11/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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