MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2015-08-06 for SURGIGUIDE GUIDE 37504 manufactured by Dentsply Implants N.v..
[22644332]
Because a second intervention is necessary, this event is reportable per 21 cfr part 803.
Patient Sequence No: 1, Text Type: N, H10
[22644333]
In this case, a dentist planned to place two different implant systems (2 xive and 4 ankylos) in one patient. The dentist ordered one surgiguide with an ankylos configuration including the tubes for both systems. However, this is not possible with simplant. The second implant system was identified as a "3. 0 fixation screw", which is not the same as the desired xive implant. In these cases, and to avoid any confusion, it is necessary to order two separate guides, one for each system to be used. The clinician stopped the surgery with just four implants (ankylos) placed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007362683-2015-00016 |
| MDR Report Key | 4990627 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2015-08-06 |
| Date of Report | 2015-05-28 |
| Date Mfgr Received | 2015-05-28 |
| Device Manufacturer Date | 2015-04-24 |
| Date Added to Maude | 2015-08-11 |
| 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 | 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 |
| Generic Name | VARIOUS, EBG, LLZ, DZE |
| Product Code | EBG |
| Date Received | 2015-08-06 |
| Returned To Mfg | 2015-07-20 |
| Catalog Number | 37504 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2015-08-06 |