MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2015-01-21 for SURGIGUIDE GUIDE 37503 manufactured by Dentsply Implants N.v..
[5393365]
According to the available info, a doctor reported that a simplant surgiguide was used for placing three implants. The dentist realized intra-operatively that the tubes were too small for the intended drills. The dentist decided to postpone the surgical treatment and ordered a new guide.
Patient Sequence No: 1, Text Type: D, B5
[12868536]
Investigation revealed that the wrong tubes were glued into the guide (sp=small platform instead of wp=wide platform). If this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such. This event, therefore, is reportable per 21cfr part 803.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007362683-2014-00004 |
| MDR Report Key | 4448113 |
| Report Source | 01,05 |
| Date Received | 2015-01-21 |
| Date of Report | 2014-10-16 |
| Date Mfgr Received | 2014-10-16 |
| Device Manufacturer Date | 2014-08-01 |
| Date Added to Maude | 2015-01-26 |
| 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 SUSQUEHANNA COMMERCE CTR W., STE 60 |
| 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 |
| Generic Name | VARIOUS, EBG, LLZ, DZE |
| Product Code | EBG |
| Date Received | 2015-01-21 |
| 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 | 2015-01-21 |