MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2014-08-28 for SURGIGUIDE 37503 manufactured by Dentsply Implants Manufacturing Gmbh.
[20783970]
In this event it was reported that an implant was removed after being placed too shallow. A surgiguide with implant depth control was used while placing the implant.
Patient Sequence No: 1, Text Type: D, B5
[20962830]
Evaluation of the model shows the surgiguide was manufactured according to the specifications ordered by the doctor. However, because a serious injury occurred, this event is reportable per 21 cfr part 803.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9681851-2014-00008 |
| MDR Report Key | 4118018 |
| Report Source | 01,05 |
| Date Received | 2014-08-28 |
| Date of Report | 2014-06-22 |
| Date Mfgr Received | 2014-06-22 |
| Date Added to Maude | 2014-09-26 |
| 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 |
| Generic Name | MULTIPLE, LLZ, DZE |
| Product Code | EBG |
| Date Received | 2014-08-28 |
| Catalog Number | 37503 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY IMPLANTS MANUFACTURING GMBH |
| Manufacturer Address | MANNHEIM GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-08-28 |