MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-09-04 for ARTIC DENTURE TEETH manufactured by Heraeus Kulzer Dental Ltd.
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(b)(6) called because she wanted to see about switching from artic to basic. She said she had patients returning soon after receiving their dentures because a tooth fractured while they were eating. She said the patient's swallow the tooth and feel the rough spot later. She said no one has been hurt yet, but they come back in very angry. She said that the denturist has been using the artic teeth for over 6 years. She said that they have had patients return over the last year all with an anterior or bicuspid broken. She said that they break between 1/3 to 1/2 up the tooth. She said that the breakage occurs on both complete and partial dentures. She said that they do not have any of the broken teeth as they have thrown them out immediately. She said she did not know which patients, moulds, or tooth shades were involved. She said she would call if this occurred again. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1925223-2013-00123 |
| MDR Report Key | 3414090 |
| Date Received | 2013-09-04 |
| Date of Report | 2013-08-06 |
| Date Facility Aware | 2013-08-06 |
| Date Added to Maude | 2013-10-17 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 4315 SOUTH LAFAYETTE BLVD. |
| Manufacturer City | SOUTH BEND IN 466142517 |
| Manufacturer Country | US |
| Manufacturer Postal | 466142517 |
| Manufacturer G1 | HERAEUS KULZER, INC., DENTAL PRODUCTS DIVISION |
| Manufacturer Street | 4315 SOUTH LAFAYETTE BLVD. |
| Manufacturer City | SOUTH BEND IN 46614251 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46614 2517 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARTIC DENTURE TEETH |
| Generic Name | ELM DENTURE, PLASTIC TEETH |
| Product Code | ELM |
| Date Received | 2013-09-04 |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HERAEUS KULZER DENTAL LTD |
| Manufacturer Address | SHANGHAI CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-09-04 |