MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,08 report with the FDA on 2012-11-27 for ORTHONOL NICKEL TITANIUM PREFORMED NATURAL ARC A0720 manufactured by Rmo, Inc..
[2997358]
It was reported that a pt in (b)(6), undergoing orthodontic treatment, had a lower. 014 inch diameter nickel titanium super elastic archwire break. The pt swallowed the small piece of broken wire section approximately. 75 inches in length. The remaining section of wire was removed and new wire replaced by the orthodontist. The pt was taken to emergency where imaging was done to determine that the wire had reached the pt's stomach. A later imaging showed the wire had passed out of the pt's system. There is no indication that this caused any health problems for the pt.
Patient Sequence No: 1, Text Type: D, B5
[10323623]
The tested wire met all performance specifications and product empirical comparison tests of the manufacturer, and showed no signs of being defective. During review of the wire breakage site, no evidence was found of a cause for premature failure.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1718476-2012-00001 |
| MDR Report Key | 2850684 |
| Report Source | 01,05,08 |
| Date Received | 2012-11-27 |
| Date of Report | 2012-11-27 |
| Date Mfgr Received | 2012-10-13 |
| Device Manufacturer Date | 2012-02-01 |
| Date Added to Maude | 2012-12-12 |
| 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 | TERRI SALANKEY |
| Manufacturer Street | 650 WEST COLFAX AVENUE |
| Manufacturer City | DENVER CO 80204 |
| Manufacturer Country | US |
| Manufacturer Postal | 80204 |
| Manufacturer Phone | 3035928217 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORTHONOL NICKEL TITANIUM PREFORMED NATURAL ARC |
| Generic Name | ORTHODONTIC ARCH WIRE |
| Product Code | DZC |
| Date Received | 2012-11-27 |
| Returned To Mfg | 2012-10-13 |
| Model Number | A0720 |
| Lot Number | F1119109 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RMO, INC. |
| Manufacturer Address | DENVER CO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-11-27 |