inforMED
InjuryEMS

AFTER FIVE GRACEY CURETTE

Received Feb 6, 2019 · Event occurred Jan 15, 2019

Report 1416605-2019-00003 · MDR key 8312699

Device

Generic name

Curette, Periodontic

Model number

SRP13/14R7

Catalog number

SRP13/14R7

Lot number

0718

Product problems

  • Material Fragmentation
  • Material Fragmentation

Patient

50 YR

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Additional Manufacturer Narrative

OTHER RELEVANT HISTORY: THERE IS NO RELEVANT HISTORY. UDI #: BASED ON THE LOT NUMBER THE UDI REQUIREMENT DOES NOT YET APPLY. ADDITIONALLY, WE DO NOT USE PRODUCT SERIALIZATION. IMPLANT DATE, EXPLANT DATE: THE DEVICE IS NOT IMPLANTED; THEREFORE, IMPLANT/EXPLANT DATES ARE NOT APPLICABLE. NAME AND ADDRESS OF REPROCESSOR: REPROCESSOR DOES NOT APPLY. CONCOMITANT MEDICAL PRODUCTS: NO KNOWN CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES. FOR USE BY USER FACILITY/IMPORTER: NOT APPLICABLE, AS WE ARE FILING THIS REPORT AS THE DEVICE MANUFACTURER.

Description of Event or Problem

THE TIP OF A CURETTE BROKE DURING NON-SURGICAL PERIODONTAL THERAPY. IT WAS BEING USED WITH NORMAL STROKE IN THE 16-17 INTERDENTAL AREA. AN X-RAY SUGGESTED IT WAS STUCK IN AN ANGULAR DEFECT AND THEN BROKE.