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 37502 manufactured by Dentsply Implants N.v..
[5386611]
A simplant surgiguide was used for planning and placing two implants. The customer reported that the length of the drills was incorrect and the tubes were fixed too deep leading to the drills going too deep into the bone.
Patient Sequence No: 1, Text Type: D, B5
[12973764]
In addition he noted that the email for approval of changes was missing. The customer was contacted several times for add'l info, and we have not had a response. While it is believed that no serious injury resulted in this event, 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 reported per 21cfr part 803. Multiple unsuccessful attempts were made to obtain the device for eval. Multiple unsuccessful attempts were made to obtain the pt outcome.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007362683-2014-00005 |
| MDR Report Key | 4448114 |
| Report Source | 01,05 |
| Date Received | 2015-01-21 |
| Date of Report | 2014-09-16 |
| Date Mfgr Received | 2014-09-16 |
| 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 | 37502 |
| Lot Number | NA |
| 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 N.V. |
| Manufacturer Address | HASSELT, LUMBURG BE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-01-21 |