PLANSCAN
Received Jun 15, 2017 · Event occurred May 12, 2017
Report 3004998675-2017-00001 · MDR key 6645328
Device
Generic name
Nof - Optical Impression System For Cad/cam Of Dental Restorations
Manufacturer
D4d Technologies, LlcModel number
PLANSCAN SCANNER TIP - STANDARDCatalog number
C12370903
Lot number
UNKNOWN
Product problems
- Fracture
- Fracture
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
PER (B)(6), ITEM THAT CRACKED WHILE IN THE PATIENTS MOUTH. BLOOD WAS UNDER THE CRACK AND WHEN THEY GOT IT OUT IT SHATTERED AT THE TIP OF THE SCREEN AND PLASTIC. (B)(6) 2017 AT 10:55 A.M. (B)(6) LEFT MESSAGE WITH (B)(4) AT FRONT DESK FOR (B)(6) TO CALL BACK. AT 3:36 P.M. CALLED AGAIN AND SPOKE WITH (B)(4) AT THE OFFICE AND (B)(6) WAS WITH PATIENTS BUT WILL BE GIVEN MESSAGE TO CAL. THEN AT 4:58 P.M. (B)(4) SPOKE WITH (B)(4) AT THE OFFICE AND SHE PROVIDED (B)(6)'S EMAIL WHICH AN E-MAIL WAS SENT FOR ADDITIONAL INFORMATION. AT 5:51 P.M. (B)(6) RESPONDED TO THE E-MAIL SENT AND PROVIDED SOME ADDITIONAL INFORMATION. SHE SAID THAT THE PART OF THE PLANSCAN SCANNER THAT CRACKED IS THE INTERNAL MIRROR AND THE EDGE OF THE OUTER RIM AT THE TIP OF THE SCANNER. THE PROCEDURE THE DOCTOR WAS PERFORMING AT THE TIME WAS INTRAORAL SCANNING FOR THE SAME DAY SEAT CROWN. SHE IS NOT AWARE OF ANY PIECES THAT FELL AS A RESULT OF THE CRACK. SHE COULD NOT SEE THE LOT NUMBER OR SERIAL NUMBER AS IT LOOKS LIKE ITS ON THE INSIDE OF THE NECK. THE PATIENT IS DOING FINE AS OF TODAY.
Remedial action
- Replace