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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WITTENSTEIN INTENS GMBH FITBONE INTRAMEDULLARY LENGTHENING NAIL

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WITTENSTEIN INTENS GMBH FITBONE INTRAMEDULLARY LENGTHENING NAIL Back to Search Results
Model Number TAA1160-F-225
Device Problem Insufficient Information (3190)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/08/2021
Event Type  malfunction  
Event Description
At dec 18th patient had an accident with overloading of the operated leg which have led to collapse of the distal fragment. At dec 30th patient was re-operated and position of the distal fragment on the nail was stabilized again. After that the surgeon was not able to start lengthening (there is no calcification of callus as a reason). The motor can still be heard, but not with the same intensity of running noise as before. Not explanted yet. The surgeon decided to heal it on the nail in anatomical position of revision surgery without prolongation. The nail will be explanted after healing is finished.
 
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Brand NameFITBONE
Type of DeviceINTRAMEDULLARY LENGTHENING NAIL
Manufacturer (Section D)
WITTENSTEIN INTENS GMBH
walter-wittenstein-str. 1
igersheim, 97999
GM 97999
Manufacturer Contact
eva lunz
walter-wittenstein-str. 1
igersheim, baden-wuerttemberg 97999
GM   97999
MDR Report Key11300516
MDR Text Key244163442
Report Number3003236810-2021-00001
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K163368
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Remedial Action Inspection
Type of Report Initial
Report Date 02/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberTAA1160-F-225
Device Catalogue Number60001468
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/11/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/17/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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