inforMED
InjuryKGS

GII

Received Jun 5, 1998 · Event occurred May 1, 1996

Report 1221934-1998-00029 · MDR key 172322

Device

Generic name

Bone Anchor

Manufacturer

Mitek Products

Model number

216655

Catalog number

216655

Lot number

UN

Product problems

  • Other (for use when an appropriate device code cannot be identified)

Patient

*

  • Unspecified Infection
  • Pain
  • Other (for use when an appropriate patient code cannot be identified)
  • Surgical procedure
  • Foreign body, removal of
  • Surgical procedure, additional

Narrative

Description of Event or Problem

PER LEGAL COMPLAINT: AS A RESULT OF HAVING A BONE ANCHOR PENETRATING HER L-5 DISK, SUFFERED SERVERE BACK PAIN AND DEVELOPED A SIGNIFICANT POST-OPERATIVE INFECTION. SHE HAS HAD TO UNDERGO ADDITIONAL GYNECOLOGICAL SURGERY TO CORRECT THE DEFECTS OF THE BLADDER AND PROLAPSE SURGERY. SHE HAS ALSO HAD TO UNDERGO ORTHOPEDIC SURGERY TO REMOVE THE FOREIGN OBJECT FROM HER DISK AND FUSE HER SPINE.