MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2013-10-30 for MONDIAL 6 manufactured by Heraeus Kulzer Gmbh.
[3782029]
(b)(4).
Patient Sequence No: 1, Text Type: D, B5
[11213706]
(b)(4). Although we have not established that the device caused or contributed to the event, we are reporting it to be compliant with 21 cfr part 803 and out of an abundance of caution. Complaint rate for this malfunction is less than (b)(4). The complaint rate is very low and within compliance range. The complaint rate will continued to be monitored. Due to the aforementioned reason, capa measures are not recommended. The lab destroyed the remaining portion of the tooth to remove and did not have knowledge of the broken portion's location.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006610834-2013-00017 |
| MDR Report Key | 3450003 |
| Report Source | 01,06 |
| Date Received | 2013-10-30 |
| Date Mfgr Received | 2013-10-04 |
| Date Added to Maude | 2013-11-07 |
| 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 46614 |
| Manufacturer Country | US |
| Manufacturer Postal | 46614 |
| 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 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MONDIAL 6 |
| Generic Name | ELM DENTURE, PLASTIC, TEETH |
| Product Code | ELM |
| Date Received | 2013-10-30 |
| 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 | 2013-10-30 |