MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-10-05 for FORSUS DIRECT PUSHROD 885-113 manufactured by 3m Unitek.
[1237470]
During a procedure to reattach a loose bracket to pt's tooth, pt swallowed a 2. 2cm orthodontic spring, which had inadvertently detached from the archwire. An endoscopy was performed to retrieve the spring from the pt's stomach, but it had already passed into the pt's intestine. A colonoscopy was then performed, and the spring was retrieved from pt's intestine. Pt is fine and continuing with his orthodontic treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020467-2009-00003 |
| MDR Report Key | 1493489 |
| Report Source | 05 |
| Date Received | 2009-10-05 |
| Date of Report | 2009-09-21 |
| Date of Event | 2009-09-19 |
| Date Mfgr Received | 2009-09-21 |
| Date Added to Maude | 2009-10-13 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARLYN SCHEFF |
| Manufacturer Street | 2724 SOUTH PECK RD. |
| Manufacturer City | MONROVIA CA 91016 |
| Manufacturer Country | US |
| Manufacturer Postal | 91016 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FORSUS DIRECT PUSHROD |
| Generic Name | ORTHODONTIC SPRING |
| Product Code | ECO |
| Date Received | 2009-10-05 |
| Model Number | NA |
| Catalog Number | 885-113 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M UNITEK |
| Manufacturer Address | MONROVIA CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-10-05 |