inforMED
MalfunctionJBS

CD HORIZON SPINAL SYSTEM

Received May 18, 2005 · Event occurred Mar 11, 2005

Report 1030489-2005-00134 · MDR key 606345

Device

Generic name

Bone Screw

Model number

NA

Catalog number

UNK

Lot number

UNK

Product problems

  • Disassembly
  • Device remains implanted

Patient

UNKNOWN

  • Unknown (for use when the patient's condition is not known)

Narrative

Description of Event or Problem

IT WAS REPORTED THAT X-RAYS TAKEN APPROX 5 1/2 MONTHS POST OP SHOWED THAT THE HEAD OF A SCREW DISASSOCIATED FROM THE SHAFT OF THE SCREW. THE DEVICE HAS NOT BEEN EXPLANTED.