PROMARK MOTOR REPLACEMENT
Received Jul 21, 2026 · Event occurred Jul 16, 2026
Report 2320721-2026-00081 · MDR key 25888152
Device
Generic name
Handpiece, Direct Drive, Ac-powered
Manufacturer
Tulsa Dental Products LlcCatalog number
PMKEM1MTR
Product problems
- Mechanical Problem
Patient
Not reported
- Insufficient Information
Narrative
Description of Event or Problem
IN THIS EVENT IT IS REPORTED THAT A PROMARK MOTOR REPLACEMENT HAS INTERMITTENT POWER AND STOPS WORKING. NO ERROR MESSAGE AND CALIBRATION IS FINE. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Additional Manufacturer Narrative
THERE HAS BEEN A PREVIOUS REPORT RECEIVED WHERE THIS MALFUNCTION HAS CAUSED FILE SEPARATION. SINCE SEPARATION OF A FILE COULD NECESSITATE MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION, THIS 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 HAS NOT BEEN RETURNED AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.