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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 60001383-00-0
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Insufficient Information (4580)
Event Date 01/15/2021
Event Type  malfunction  
Event Description
Information provided states that the patient had a fitbone nail implanted in the femur on (b)(6) 2020. It was noticed during a post-op visit on (b)(6) 2021 that there was no lengthening of the nail. The distributor representative tested the nail for distraction on (b)(6) 2021 using a 2nd control unit. The nail failed to lengthen with the new control unit. A revision surgery will be scheduled to further patient's treatment.
 
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Brand NameFITBONE
Type of DeviceINTRAMEDULLARY LENGTHENING NAIL
Manufacturer (Section D)
WITTENSTEIN INTENS GMBH
walter-wittenstein-str. 1
igersheim, germany 97999
GM 97999
MDR Report Key11325533
MDR Text Key245491218
Report Number2183449-2021-00001
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 01/20/2021,02/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number60001383-00-0
Device Catalogue Number60001383-00-0
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Distributor Facility Aware Date01/15/2021
Event Location Home
Date Report to Manufacturer01/20/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 02/12/2021 Patient Sequence Number: 1
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