MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1996-09-25 for ALASTIK "S" MODULES (SEPARATORS) 406-084 manufactured by 3m Unitek Corporation.
[21748]
Separator was placed in 4/95 between tooth #2 and tooth #3. Orthodontist subsequently placed a band on tooth #2, unaware that the separator had migrated gingivally. Orthodontist noted in 12/95 that the pt had an infection between tooth #2 and tooth #3 and referred pt to a dentist. Pt was placed on antibiotics for infection. Pt was then referred to an endodontist for diagnosis, but endodontist could not determine cause of infection. In 7/96 pt was referred to a peridontist for evaluation. Peridontist found separator and performed a peridontal surgical flap procedure to remove separator. Orthodontist stated that pt's prognosis is good.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020467-1996-00011 |
| MDR Report Key | 39783 |
| Report Source | 05 |
| Date Received | 1996-09-25 |
| Date of Report | 1996-08-27 |
| Date of Event | 1995-12-01 |
| Date Mfgr Received | 1996-08-27 |
| Date Added to Maude | 1996-09-30 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALASTIK "S" MODULES (SEPARATORS) |
| Generic Name | ORTHODONTIC ELASTIC BAND |
| Product Code | ECI |
| Date Received | 1996-09-25 |
| Model Number | NA |
| Catalog Number | 406-084 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 40915 |
| Manufacturer | 3M UNITEK CORPORATION |
| Manufacturer Address | 2724 SOUTH PECK RD MONROVIA CA 91016 US |
| Baseline Brand Name | ALASTIK "S" MODULES |
| Baseline Generic Name | ORTHODONTIC ELASTIC BAND |
| Baseline Model No | 406-084 |
| Baseline Catalog No | 406-084 |
| Baseline ID | * |
| Baseline Device Family | SEPARATORS |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1996-09-25 |