FDA Adverse Event
Injury
Summary report: N
ALASTIK "S" MODULES (SEPARATORS)
MDR report key: 39783
·
Received September 25, 1996
Report
- Report Number
- 2020467-1996-00011
- Event Type
- Injury
- Date Received
- September 25, 1996
- Date of Event
- December 1, 1995
- Report Date
- August 27, 1996
- Manufacturer
- 3M UNITEK CORPORATION
- Product Code
- ECI
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALASTIK "S" MODULES (SEPARATORS) | ORTHODONTIC ELASTIC BAND | ECI | 3M UNITEK CORPORATION | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 14 YR | Required Intervention | TREATMENT.| ORTHODONTIST STATED THAT PT HAD TRADITIONAL BRACES| BANDS AND ARCHWIRES PLACE ON TEETH FOR ORTHODONTIC |