MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-08-13 for MONDIAL 6 A1 L362 66016863 manufactured by Heraeus Kulzer Gmbh.
[3836729]
This is the fifth of thirteen device reports from one dental lab. A dental lab notified local (b)(6) rep of mondial teeth they want to replace due to shearing. The lab did not give individual info on pts and dates. The hk rep explained that this happens with the all-on 4's and the fact that the teeth shear before the implant does is a good thing. On (b)(6) 2013, contacted the denture set up guys from the lab. They said the teeth sheared while in the pt's mouth. They said the pt would bite down on something and shear a tooth at the gum line. They would drill the rest of the tooth out and replace the tooth. There was no incident of a pt being injured from this, no aspiration or ingestion. On (b)(6) 2013, sent a list of questions for the lab concerning the shearing of teeth. The lab declined to respond to these questions. The lab no longer has the teeth therefore they will not be returning them for eval. This incident involved denture tooth #27. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1925223-2013-00103 |
| MDR Report Key | 3300138 |
| Date Received | 2013-08-13 |
| Date of Report | 2013-06-06 |
| Date Facility Aware | 2013-06-06 |
| Date Added to Maude | 2013-08-22 |
| 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 | MONDIAL 6 |
| Product Code | ELM |
| Date Received | 2013-08-13 |
| Model Number | A1 L362 |
| Catalog Number | 66016863 |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HERAEUS KULZER GMBH |
| Manufacturer Address | WASSERBURG 88142 GM 88142 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-08-13 |