MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2016-09-14 for VECTORTAS MINI SCREW manufactured by Ormco Corporation.
[54685790]
It was alleged that a patient had and allergic reaction; however no further specific information has been received at this time. An update will be provided upon receipt of new information.
Patient Sequence No: 1, Text Type: N, H10
[54685791]
It was alleged that a patient had an allergic reaction to vectortas screws.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 2016150-2016-00003 |
MDR Report Key | 5949579 |
Report Source | OTHER |
Date Received | 2016-09-14 |
Date of Report | 2016-09-02 |
Date Added to Maude | 2016-09-14 |
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 | 0 |
Initial Report to FDA | 0 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | MRS. SUZETTE RAMPAIR-JOHNSON |
Manufacturer Street | 1332 SOUTH LONE HILL AVENUE |
Manufacturer City | GLENDORA CA 91740 |
Manufacturer Country | US |
Manufacturer Postal | 91740 |
Manufacturer Phone | 9099625730 |
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 | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | VECTORTAS MINI SCREW |
Generic Name | VECTORTAS MINI SCREW |
Product Code | OAT |
Date Received | 2016-09-14 |
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 | 2016-09-14 |