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U.S. Department of Health and Human Services

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

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WITTENSTEIN INTENS GMBH FITBONE INTRAMEDUALLARY LENGTHENING NAIL Back to Search Results
Model Number TAA1160-T-225
Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978)
Patient Problems Pain (1994); Patient Problem/Medical Problem (2688)
Event Date 08/07/2017
Event Type  malfunction  
Event Description
The patient has fully weight-loaded the implant for one year (only partial weight-loading is allowed during the active phase and until full consolidation). The patient had pain in the leg. An x-ray examination showed that the implant was broken. The nail was explanted and a rigid nail was implanted for stabilization.
 
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Brand NameFITBONE
Type of DeviceINTRAMEDUALLARY 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 Key9887412
MDR Text Key189497175
Report Number3003236810-2020-00002
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 health professional,user faci
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 Date11/25/2015
Device Model NumberTAA1160-T-225
Device Catalogue Number60001445
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/07/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/07/2016
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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