LENTULO RA 21MM 2
Received Oct 17, 2019
Report 2320721-2019-00207 · MDR key 9203252
Device
Generic name
Instrument, Filling, Plastic, Dental
Manufacturer
Tulsa Dental Products LlcModel number
NACatalog number
671561
Lot number
1324846
Product problems
- Break
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Information
- No Known Impact Or Consequence To Patient
- No Information
Narrative
Additional Manufacturer Narrative
INVOLVED PRODUCTS THAT BROKE DURING USE WERE NOT RETURNED AND CANNOT BE ANALYZED. MOREOVER, NO UNUSED GATE IS AVAILABLE FOR EVALUATION. NOTHING UNUSUAL TO REPORT WAS FOUND DURING DHRS REVIEW (BATCHES #1283483 AND #1324846). ROOT CAUSES ARE NOT IDENTIFIED. WE WILL TRACK THIS KIND OF EVENT AND MONITOR THE TREND. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO OBTAIN THE PATIENT OUTCOME.
Additional Manufacturer Narrative
AS A RESULT OF THIS MALFUNCTION, THE POTENTIAL FOR SURGICAL INTERVENTION EXISTS TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION AS EVIDENCED BY PREVIOUS REPORTED EVENTS WITH SIMILAR FILES. THIS EVENT, THEREFORE, IS REPORTABLE PER 21CFR PART 803. THIS REPORT IS FOR THE SECOND DEVICE. THE DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, THE LOT NUMBER WAS PROVIDED AND RETAINED-PRODUCT TESTING AND/OR DHR REVIEW ARE PLANNED. THE RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO OBTAIN THE PATIENT OUTCOME.
Description of Event or Problem
IN THIS EVENT IT WAS REPORTED TWO GATES FILE LENTULO RA 21MM 2 BROKE DURING INITIAL USE. THE EVENT OUTCOME IS UNKNOWN AS OF THIS MDR EVALUATION.