• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

WITTENSTEIN INTENS GMBH FITBONE INTRAMEDULLARY LENGTHENING NAIL Back to Search Results
Model Number TAA1160-F-225
Device Problems Break (1069); Fracture (1260)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/22/2020
Event Type  malfunction  
Event Description
A fracture of the implant was detected while its regular explantation. According to the clinic, this can already be seen retrospectively on the x-rays. The removal of the implant took place with increased effort for the surgeon. Negative consequences for the patient are not yet known.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key10983932
MDR Text Key220727295
Report Number3003236810-2020-00014
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 12/10/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/29/2020
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 Received11/10/2020
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

-
-