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MDA/2007/088 - Injectable polymeric cements used in percutaneous vertebroplasty, balloon kyphoplasty and pedicle screw augmentation

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Document details:

Type: Medical Device Alert
Series No: MDA/2007/088
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 4
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Page 1

Issued: 27 November 2007 at 14:30
Ref: MDA/2007/088

 

 
Immediate action
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Action
Tick mark
Update
 
Information request


Device:
Injectable polymeric cements used in percutaneous vertebroplasty, balloon kyphoplasty and pedicle screw augmentation.		  
Problem:
Inappropriate use, or modification, of cement composition leading to serious complications (an update).

>Page 2

Action by:
Clinicians carrying out percutaneous vertebroplasty, balloon kyphoplasty or pedicle screw augmentation.

>Page 2

Action:

  • Note the revised recommendations on percutaneous vertebroplasty and balloon kyphoplasty, which supersede the advice given in MDA/2004/027 (issued in June 2004).
  • Destroy all copies of MDA/2004/027.

>Pages 2-3

Distributed to:

NHS trusts in England - Chief Executives*
Healthcare Commission (CHAI) - Headquarters

* via CE Bulletin

>Page 3

Contacts:
Details of MHRA contacts for technical and clinical aspects.
Change of address or removal from address list for Healthcare Commission.

>Page 4



Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 27 February 2008
Deadline (action complete): 27 May 2008


Page last modified: 27 November 2007