MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2011-03-31 for DEGUDENT U 5313020002 manufactured by Degudent Gmbh.
[19944841]
Investigation showed that the fracture was caused exclusively by use error. As such, there is no indication that the device involved malfunctioned. However, since healthy tooth structure was damaged and intervention was required as a result, this event meets the criteria for reportability per 21 cfr part 803. The device was returned and macroscopic inspection and microsection evaluations were performed. Massive abrasion, numerous blow holes, and blow holes in solder joint were noted. The customer was advised to check and improve casting parameters in order to attain better casting quality. In the case of massive abrasion, the bridge should be stabilized by enlarging the connector cross section and using a lingual metal garland. The solder fissure should be kept between 0. 05 and 0. 2 mm.
Patient Sequence No: 1, Text Type: N, H10
[20086304]
In this event, it was reported that a four-part degudent u bridge fractured in a pt's mouth after four years in place. A tooth under the bridge also fractured. As a result, the tooth was restored; no further issues were reported after restoration.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681199-2011-00001 |
| MDR Report Key | 2058955 |
| Report Source | 01 |
| Date Received | 2011-03-31 |
| Date of Report | 2011-03-01 |
| Date Mfgr Received | 2011-03-01 |
| Date Added to Maude | 2011-04-19 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | HELEN LEWIS |
| Manufacturer Street | 221 W. PHILA. ST., STE. 60 SUSQUEHANNA COMMERCE CTR W. |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178457511 |
| Manufacturer G1 | DEGUDENT GMBH |
| Manufacturer Street | RODENBACHER CHAUSSEE 4 |
| Manufacturer City | HANAU/WOLFGANG D-63457 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-63457 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEGUDENT U |
| Product Code | EJT |
| Date Received | 2011-03-31 |
| Returned To Mfg | 2011-03-01 |
| Catalog Number | 5313020002 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEGUDENT GMBH |
| Manufacturer Address | HANAU GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-03-31 |