VECTORTAS MINI SCREW
Received Aug 8, 2013
Report 2016150-2013-00074 · MDR key 3271049
Device
Generic name
Implant, Transmandibular
Manufacturer
Ormco CorporationCatalog number
601-0021
Lot number
112911
Product problems
- Break
- Nonstandard Device
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
PATIENT SPECIFICS WITH REGARD TO AGE AND GENDER WERE NOT PROVIDED. THE PATIENT WAS REFERRED TO AN ORAL SURGEON. THE ORAL SURGEON EXTRACTED THE PORTION OF THE SCREW. TO DATE, THE PATIENT IS DOING FINE. THE PRODUCT INVOLVED IN THE ALLEGED INCIDENT HAS NOT BEEN RETURNED. THE LOT NUMBER 112911 HAS BEEN IDENTIFIED AS AN AFFECTIVE LOT WHICH IS PART OF AN ONGOING VECTOR TAS RECALL; THEREFORE, NO FURTHER EVALUATIONS ARE NECESSARY.
Description of Event or Problem
A DOCTOR ALLEGED THAT ONE (1) VECTORTAS 8MM MINI SCREW HAD BROKEN AT THE GUM LEVEL DURING PLACEMENT.
Remedial action
- Recall