MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2014-03-14 for SPIRIT MB 202-0069 manufactured by Ormco Corporation.
[4295108]
A dealer reported that a doctor's office alleged that spirit mb identification dot is located on the incorrect area of the bracket.
Patient Sequence No: 1, Text Type: D, B5
[11569018]
No injuries were associated with this incident. The doctor noticed the marking was in the wrong area and stopped using the device. Pictures of the product alleged in this incident confirmed that the identification dot is located on the incorrect area of the bracket. A retain sample of the product was evaluated, yielding results within specifications.
Patient Sequence No: 1, Text Type: N, H10
[33378915]
Sybronendo corporation was informed on 04/14/2014 by a dealer representative that the wrong item number and description was given on the initial complaint report. The correct item number involved in the alleged incident is 202-0069 and the description is channels 21mm files.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2016150-2014-00023 |
| MDR Report Key | 3679839 |
| Report Source | * |
| Date Received | 2014-03-14 |
| Date of Report | 2014-02-14 |
| Date Mfgr Received | 2014-02-14 |
| Date Added to Maude | 2014-05-16 |
| 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 | 0 |
| 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 | SPIRIT MB |
| Generic Name | ORTHODONTIC BRACKET, PLASTIC |
| Product Code | DYW |
| Date Received | 2014-03-14 |
| Catalog Number | 202-0069 |
| Lot Number | 081351013 |
| Device Availability | N |
| Device Age | DA |
| 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 | 2014-03-14 |