inforMED
InjuryEEF

HYGENIC

Received Sep 6, 2022 · Event occurred Jul 8, 2022

Report 2416455-2022-00010 · MDR key 15365990

Device

Generic name

Dental Dam Clamp

Catalog number

H09966

Product problems

  • Fracture
  • Fracture

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

ON (B)(6) 2022, CUSTOMER STATED THAT MOLARS CLAMPS SETS 13A AND 12A WERE USED ON MAXILLARY MOLAR 4 AND BOTH SETS FRACTURED DURING USE, WITHOUT WARNING BETWEEN 1ST USAGE AND 10TH USAGE. ON ALL OCCASIONS, CLAMPS FLOSSED AND RETRIEVED WITHOUT INCIDENT. ALL CLAMPS RUSTED WITH SODIUM HYPOCHLORITE USE (5.25%). ADDITIONAL INFORMATION WAS PROVIDED ON 08/08/2022 AS FOLLOWS: THE CLAMPS BROKE DURING THE PROCEDURE. THE FIRST ONE AT ABOUT 15-30 MINUTES INTO THE PROCEDURE, AND THE SECOND ONE AT ABOUT ONE HOUR INTO THE PROCEDURE. ON BOTH OCCASIONS, THE DENTAL DAM CAME OFF THE TOOTH.