MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-01 for SURGIGUIDE 37501 manufactured by Dentsply Implants N.v..
[54427088]
There has been a previous report received where this malfunction resulted in a serious injury. Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such. As such, this event is reportable per 21cfr part 803. The device is available for evaluation, though results are not available as of this report. Evaluation results will be submitted as they become available.
Patient Sequence No: 1, Text Type: N, H10
[54427089]
It was reported that a surgiguide was used to place a dental implant. The implant transfer was too shallow and the guide did not fit. The clinician reported that additional steps during the surgery were needed to place the implant deeper. A second corrective surgery was not needed.
Patient Sequence No: 1, Text Type: D, B5
[57826904]
The products have been returned and investigation shows that the product has been manufactured according to our standards. The fit on the model was good, the product has been finished correctly, the matching of the digital plaster model was good as well as the extractions performed on the stone model.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007362683-2016-00009 |
| MDR Report Key | 5923696 |
| Date Received | 2016-09-01 |
| Date of Report | 2016-08-05 |
| Date Mfgr Received | 2016-09-19 |
| Date Added to Maude | 2016-09-01 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. HELEN LEWIS |
| Manufacturer Street | 221 W. PHILADELPHIA ST. SUITE 60W |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178494229 |
| Manufacturer G1 | DENTSPLY IMPLANTS N.V. |
| Manufacturer Street | RESEARCH CAMPUS 10 |
| Manufacturer City | HASSELT LIMBURG, B-3500 |
| Manufacturer Country | BE |
| Manufacturer Postal Code | B-3500 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SURGIGUIDE |
| Generic Name | SYSTEM, IMAGE PROCESSING, RADIOLOGICAL |
| Product Code | LLZ |
| Date Received | 2016-09-01 |
| Returned To Mfg | 2016-08-05 |
| Model Number | NA |
| Catalog Number | 37501 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY IMPLANTS N.V. |
| Manufacturer Address | RESEARCH CAMPUS 10 HASSELT LIMBURG, B-3500 BE B-3500 |
| Product Code | DZE |
| Date Received | 2016-09-01 |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Product Code | EBG |
| Date Received | 2016-09-01 |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-09-01 |