MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,07 report with the FDA on 2013-08-13 for MONDIAL 6 manufactured by Heraeus Kulzer Gmbh.
[20335057]
(b)(4).
Patient Sequence No: 1, Text Type: D, B5
[20556457]
As allowed by exemption (b)(4), (b)(4) (the importer) is submitting the report on behalf of heraeus kulzer (b)(4) (the mfr). Although we have not established that the device caused or contributed to the event, we're reporting it to be compliant with 21 cfr part 803 and out of an abundance of caution. Conclusion code: weakening of artificial teeth through excessive trimming out of teeth especially in retention areas in the framework and the drilling of retention holes in teeth. Improper fitting of device due to implant pts often lack of feeling for their occlusal load. We are closely working with the labs that have experienced this issue as most labs do not have any breakage issues. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006610834-2013-00010 |
| MDR Report Key | 3300015 |
| Report Source | 00,07 |
| Date Received | 2013-08-13 |
| Date Mfgr Received | 2013-06-06 |
| Date Added to Maude | 2013-08-22 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | AUDI BOGUCKI, RDH |
| Manufacturer Street | 300 HERAEUS WAY |
| Manufacturer City | SOUTH BEND IN 466140000 |
| Manufacturer Country | US |
| Manufacturer Postal | 466140000 |
| Manufacturer Phone | 5742995409 |
| Manufacturer G1 | HERAEUS KULZER GMBH |
| Manufacturer Street | SCHLATTEREST 2 |
| Manufacturer City | WASSERBURG 88142 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 88142 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MONDIAL 6 |
| Product Code | ELM |
| Date Received | 2013-08-13 |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 |