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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 RECEIVER
Device Problems Use of Device Problem (1670); Device Handling Problem (3265)
Patient Problem No Code Available (3191)
Event Date 07/04/2018
Event Type  malfunction  
Event Description
According to the surgeon, the intraoperative testing was usual, the implant seemed working. The lengthening procedure should start seven days after implantation. The implant didn't lengthen at this time. It seemed that the receiver was not working. Removal of receiver and replacement with a new one. After replacement the receiver works and the lengthening procedure works as usual.
 
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Brand NameFITBONE
Type of DeviceINTRAMEDULLARY LENGTHENING NAIL
Manufacturer (Section D)
WITTENSTEIN INTENS GMBH
walter-wittenstein-str. 1
igersheim, baden-wuerttemberg 97999
GM 97999
Manufacturer Contact
eva lunz
walter-wittenstein-str. 1
igersheim, baden-wuerttemberg 97999
GM   97999
MDR Report Key9887417
MDR Text Key189497144
Report Number3003236810-2020-00004
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K163368
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Remedial Action Replace
Type of Report Initial
Report Date 03/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/22/2021
Device Model NumberRECEIVER
Device Catalogue Number60001615
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/09/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/16/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/23/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/27/2020 Patient Sequence Number: 1
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