MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2001-08-07 for INVISALIGN SYSTEM * manufactured by Align Technology.
[210812]
While using an aligner (clear plastic tray designed to move teeth to correct malocclusion) a pt inadvertently pulled out a tooth when removing the pt's aligner. The pt had just had a planned tooth extraction and was told by the pt's oral surgeon to insert the pt's aligner immediately after the extraction. (align advises orthodontists that the aligner not be worn for at least 2 weeks after extraction. ) upon removal of the aligner the pt pulled out the tooth adjacent to the extraction site while still under the influence of pain medication. The pt returned to the oral surgeon who wired the tooth back in place. Align will send an advisory notice reminding orthodontists of the two week recommendation to allow for the extraction site to heal prior to wearing the aligner.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2953749-2001-00001 |
| MDR Report Key | 348524 |
| Report Source | 05 |
| Date Received | 2001-08-07 |
| Date of Report | 2001-08-02 |
| Date of Event | 2001-07-07 |
| Date Mfgr Received | 2001-07-09 |
| Device Manufacturer Date | 2001-06-01 |
| Date Added to Maude | 2001-08-27 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | MICHELLE PAGANINI, DIRECTOR |
| Manufacturer Street | 851 MARTIN AVE |
| Manufacturer City | SANTA CLARA CA 95050 |
| Manufacturer Country | US |
| Manufacturer Postal | 95050 |
| Manufacturer Phone | 4084701159 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INVISALIGN SYSTEM |
| Generic Name | ORTHODONTIC APPLIANCE |
| Product Code | KMY |
| Date Received | 2001-08-07 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 337844 |
| Manufacturer | ALIGN TECHNOLOGY |
| Manufacturer Address | 851 MARTIN AVE SANTA CLARA CA 95050 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2001-08-07 |