MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-08-08 for VECTORTAS MINI SCREW 601-0021 manufactured by Ormco Corporation.
[3634115]
A doctor alleged that one (1) vectortas 8mm mini screw had broken at the gum level during placement.
Patient Sequence No: 1, Text Type: D, B5
[10943377]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2016150-2013-00074 |
| MDR Report Key | 3271049 |
| Report Source | 05 |
| Date Received | 2013-08-08 |
| Date of Report | 2013-08-02 |
| Date Mfgr Received | 2013-08-02 |
| Date Added to Maude | 2013-08-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MRS. KERRI CASINO |
| Manufacturer Street | 1717 W COLLINS AVE |
| Manufacturer City | ORANGE CA 92867 |
| Manufacturer Country | US |
| Manufacturer Postal | 92867 |
| Manufacturer Phone | 7145167634 |
| Manufacturer G1 | ORMCO CORPORATION |
| Manufacturer Street | 1332 SOUTH LONE HILL AVENUE |
| Manufacturer City | GLENDORA CA 91740 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91740 |
| Single Use | 0 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VECTORTAS MINI SCREW |
| Generic Name | IMPLANT, TRANSMANDIBULAR |
| Product Code | MDL |
| Date Received | 2013-08-08 |
| Catalog Number | 601-0021 |
| Lot Number | 112911 |
| Operator | OTHER |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORMCO CORPORATION |
| Manufacturer Address | 1332 SOUTH LONE HILL AVENUE GLENDORA CA 91740 US 91740 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2013-08-08 |