inforMED
OtherEMG

HU-FRIEDY PERIOTOME

Received Jul 19, 2013 · Event occurred May 13, 2013

Report 1416605-2013-00003 · MDR key 3247581

Device

Generic name

Periotome

Model number

NA

Catalog number

NA

Lot number

NA

Product problems

  • Detachment Of Device Component

Patient

52 YR

  • Device Embedded In Tissue or Plaque

Narrative

Description of Event or Problem

DURING A DENTAL PROCEDURE INVOLVING UPPER IMPLANTS AND EXTRACTION OF NUMBER 4 TOOTH, A TIP OF A PERIOTOME BROKE OFF IN THE SOCKET AND WAS NOT LOCATED DURING THE PROCEDURE. AFTER THE PROCEDURE, X-RAY TAKEN IDENTIFIED THE PERIOTOME TIP WAS FOUND IN THE SINUS. A LATER CAT SCAN OF THE SINUS WAS REVIEWED BY ENT WHO REPORTED THAT THE LINEAR METALLIC OPACITY WAS CONFINED TO SOFT TISSUE RIGHT PREMAXILLA WITH SUPERIOR PORTION EXTENDING TO LEVEL OF INFRAORBITAL NERVE. SURGERY IS BEING PLANNED TO REMOVE THE TIP.

Additional Manufacturer Narrative

INFORMATION WAS COLLECTED FROM MEDWATCH FORM 3500 PROVIDED BY THE INSTITUTION. THE MANUFACTURING DATE IS NOT KNOWN BECAUSE THE INSTRUMENT WAS NOT RETURNED.

Remedial action

  • Other