BASE RX SGL 022/LR7 -30T -1A 4D
Received Jan 10, 2019
Report 2418500-2018-00002 · MDR key 8233394
Device
Generic name
Tube, Orthodontic
Manufacturer
Dentsply Sirona Orthodontics Inc.Model number
NACatalog number
268-372-80
Lot number
00124602
Product problems
- Product Quality Problem
- Inadequacy of Device Shape and/or Size
- Structural Problem
- Inadequacy of Device Shape and/or Size
Patient
Not reported
- Therapeutic Effects, Unexpected
- Complaint, Ill-Defined
- Therapeutic Effects, Unexpected
- Complaint, Ill-Defined
Narrative
Additional Manufacturer Narrative
THEREFORE, BECAUSE INTERVENTION WAS REQUIRED, THIS EVENT IS REPORTABLE PER 21CFR 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.
Description of Event or Problem
A DOCTOR CLAIMS THAT THE NEW BASE RX SKUS HAVE A LOWER PROFILE AND AS A RESULT THEY ARE SEEING AN UNWANTED ERUPTION OF THE MOLARS AND THIS IS PROLONGING TREATMENT TIMES FOR THE PATIENTS.
Additional Manufacturer Narrative
MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO OBTAIN THE DEVICE FOR EVALUATION. A DHR REVIEW WAS CONDUCTED WITH NO DISCREPANCIES NOTED.