MOPS
Received Sep 14, 2021 · Event occurred Aug 25, 2021
Report 3008846606-2021-00001 · MDR key 12466334
Device
Generic name
Instrument, Cutting, Operative
Model number
NACatalog number
ASM-20010-04
Lot number
050321-00003
Product problems
- Material Fragmentation
Patient
29 YR
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
AS A RESULT OF THE MALFUNCTION, SURGICAL INTERVENTION WAS REQUIRED TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE, THEREFORE 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
THE TIP OF THE PERFORATION SCREW (MOPS) BROKE IN THE SOFT TISSUE DURING A ORTHODONTIC PROCEDURE. THE PATIENT WAS REFERRED TO AN ORAL SURGEON WHERE THE FRAGMENT WAS SURGICALLY REMOVED AND BONE GRAFTING WAS PERFORMED TO PREVENT POSSIBLE TOOTH LOSS.