InjuryEMS
AFTER FIVE GRACEY
Received Jan 10, 2019
Report 1416605-2019-00001 · MDR key 8236343
Device
Generic name
Curette, Periodontic
Manufacturer
Hu-friedy Mfg. Co. LlcModel number
SRP15/16R9Catalog number
SRP15/16R9
Lot number
0615
Product problems
- Material Fragmentation
- Material Fragmentation
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
DATE OF EVENT IS UNKNOWN. THERE ARE NO RELEVANT TESTS/LABORATORY DATA. THERE IS NO RELEVANT HISTORY. THIS IS A CLASS I DEVICE AND BASED ON THE LOT NUMBER THE UDI REQUIREMENT DOES NOT YET APPLY. ADDITIONALLY, WE DO NOT USE PRODUCT SERIALIZATION. THE DEVICE IS NOT IMPLANTED, THEREFORE IMPLANT/EXPLANT DATES ARE NOT APPLICABLE. NO KNOWN CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES.
Description of Event or Problem
DURING A SCALING AND ROOT PLANING PROCEDURE, THE INSTRUMENT TIP BROKE SUBGINGIVALLY IN A PATIENT'S MOUTH.