MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,foreign,health professi report with the FDA on 2015-04-14 for SURGIGUIDE 37502 manufactured by Dentsply Implants N.v..
[16178084]
A customer reported they were able use a surgi-guide to place implants on the right side only. They were not able to use the guide on the left side because the abutment was rotated.
Patient Sequence No: 1, Text Type: D, B5
[16340937]
The investigation showed that the rotation was incorrect due to an error in the implant library. Therefore, because the surgery could not be completed due to the malfunction and an additional surgery is needed, this event is reportable per 21 cfr part 803.
Patient Sequence No: 1, Text Type: N, H10
[56362867]
This report was incorrectly submitted due to a misunderstanding of the complaint. The surgiguide did not malfunction, nor did it cause or contribute to a death or serious injury. The surgiguide was a concomitant product in the event. The device that malfunctioned and caused the event to happen was the atlantis abutment. A separate mdr will be submitted for the abutment.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007362683-2015-00003 |
| MDR Report Key | 4702899 |
| Report Source | 01,05,FOREIGN,HEALTH PROFESSI |
| Date Received | 2015-04-14 |
| Date of Report | 2014-10-15 |
| Date Mfgr Received | 2015-06-29 |
| Device Manufacturer Date | 2014-09-01 |
| Date Added to Maude | 2015-04-20 |
| 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 | SUSQUEHANNA COMMERCE CENTER W. 221 W. PHILADELPHIA ST., 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 |
| Generic Name | VARIOUS |
| Product Code | EBG |
| Date Received | 2015-04-14 |
| 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 LIMBURG BE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-04-14 |