MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2015-07-29 for SURGIGUIDE GUIDE VARIOUS, EBG, LLZ, DZE 37503 manufactured by Dentsply Implants N.v..
[21331615]
In this case, a customer planned to place three implants by the support of a surgiguide. Intraoperatively, the guide broke between the planned implants in region #13 and #14, when the dentist used the punch to remove soft tissue. Therefore, the dentist aborted the surgical treatment.
Patient Sequence No: 1, Text Type: D, B5
[21702369]
Therefore, because treatment could not be completed, this event is reportable per 21 cfr part 803. The guide fracture was caused by a combination of an inaccurate plaster model and possible removal of too much material during production process.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007362683-2015-00010 |
| MDR Report Key | 4961236 |
| Report Source | 01,05 |
| Date Received | 2015-07-29 |
| Date of Report | 2015-03-27 |
| Date of Event | 2015-02-04 |
| Date Mfgr Received | 2015-03-27 |
| Date Added to Maude | 2015-08-04 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | HELEN LEWIS |
| Manufacturer Street | 221 W.PHILADELPHIA ST., STE 60 SUSQUEHANNA COMMERCE CENTER W. |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178457511 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SURGIGUIDE GUIDE VARIOUS, EBG, LLZ, DZE |
| Generic Name | VARIOUS, EBG, LLZ, DZE |
| Product Code | EBG |
| Date Received | 2015-07-29 |
| Returned To Mfg | 2015-04-17 |
| Catalog Number | 37503 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY IMPLANTS N.V. |
| Manufacturer Address | HASSELT LIMBURG BE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-07-29 |