MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2013-09-26 for MONDIAL 8 (DEVICE 2) A1 / 33L 66017296 manufactured by Heraeus Kulzer Gmbh.
[3732733]
This is the second of two reports on two separate devices for one incident. (b)(6) 2013 - the dentist called because he had a very upset pt that had just received her implant retained bridge one month ago and three of the teeth broke. He said that teeth 21, 22, and 23 broke. He has the pieces and needs immediate replacement. He said that the pt is upset but otherwise fine. (b)(6) 2013 - spoke to lab technician. He said that he has made many all on 4 implants and dentures using mondial and never had this before. He said that this was the full mouth fixed all on 4 style implant. He said it is probably the pt's inability to feel that caused the breakage issue. Mfr ref # 3006610834-2013-00016.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1925223-2013-00141 |
| MDR Report Key | 3451502 |
| Report Source | 99 |
| Date Received | 2013-09-26 |
| Date of Report | 2013-08-30 |
| Date Facility Aware | 2013-08-30 |
| Date Added to Maude | 2013-11-07 |
| 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 |
| Reporter Occupation | DENTIST |
| 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 | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MONDIAL 8 (DEVICE 2) |
| Generic Name | ELM DENTURE, PLASTIC, TEETH |
| Product Code | ELM |
| Date Received | 2013-09-26 |
| Returned To Mfg | 2013-09-09 |
| Model Number | A1 / 33L |
| Catalog Number | 66017296 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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 | 2013-09-26 |