FDA Logo links to FDA home pageCenter for Devices and Radiological Health, U.S. Food and Drug AdministrationHHS Logo links to Department of Health and Human Services website

FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH U.S. Food and Drug Administration Center for Devices and Radiological Health [Skip navigation]
horizonal rule
Super Search
510(k) | Registration & Listing | Adverse Events | PMA | Classification | CLIA
CFR Title 21 | Advisory Committees | Assembler | Recalls | Guidance | Standards
 

 

Adverse Event Report

ELECTRO-BIOLOGY, INC. SMALL FIXATOR FIXATOR, SMALL MODEL KIT   back to search results
Catalog Number 30-000
Event Date 03/05/1996
Patient Outcome  Other;
Event Description

Child with fracture of right femur. To or on 3/5/96 for application of external fixator device. Displacement of device noted. Pt required return to or on 3/7/96. During pre-op manipulation of 2nd device, 2nd device broke. Third device then placed in pt, successfully.

 
Search Alerts/Recalls

  new search  |  submit an adverse event report

Brand NameSMALL FIXATOR
Type of DeviceFIXATOR, SMALL MODEL KIT
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
ELECTRO-BIOLOGY, INC.
parsippany NJ 07054
Manufacturer (Section D)
ELECTRO-BIOLOGY, INC.
parsippany NJ 07054
Device Event Key36651
MDR Report Key35232
Event Key33123
Report Number35232
Device Sequence Number1
Product CodeHTY
Report Source User Facility
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 03/08/1996
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/18/1996
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number30-000
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Device Ageno info
Event Location Hospital
Is the Device an Implant? Yes
Is this an Explanted Device?

Database last updated on February 28, 2009

horizonal rule

CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

Center for Devices and Radiological Health / CDRH