PALODENT PLUS FORCEPS
Received Jan 16, 2013
Report 2515379-2013-00001 · MDR key 2928927
Device
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Tooth Fracture
Narrative
Description of Event or Problem
IN THIS EVENT, IT WAS REPORTED THAT A PAIR OF PALODENT PLUS FORCEPS DID NOT HAVE A GOOD GRIP ON A MATRIX RING AND AS A RESULT, THE RING "JUMPED OFF" THE FORCEPS AND CHIPPED THE TOOTH OF A PATIENT. IT IS UNKNOWN IF A RESTORATION HAS BEEN COMPLETED.
Additional Manufacturer Narrative
BECAUSE EVALUATION OF THE UNIT INVOLVED IS NOT COMPLETE AS OF THIS REPORT AND SINCE THIS COULD NECESSITATE MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION, IT MUST BE PRESUMED THAT THE DEVICE MALFUNCTIONED AND THAT THE MALFUNCTION WOULD BE LIKELY TO CAUSE/CONTRIBUTE TO A SERIOUS INJURY SHOULD IT RECUR. AS SUCH, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH RESULTS ARE NOT AVAILABLE AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.