MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-12-31 for REDUCTION GUIDE 54500227 manufactured by Dentsply Implants N.v..
[5289313]
In this event it was reported that a simplant reduction guide fractured while the pt was under sedation. The guide was used intraoperatively to indicate the bone volume which needed to be reduced prior to implant placement. Due to lack of guidance the dentist decided to abort the surgical treatment and an additional unplanned procedure became necessary.
Patient Sequence No: 1, Text Type: D, B5
[12653365]
According to the investigation, the reduction guide was too fragile to be useful for the resection of the bone due to the position of implants close to the foramen. To correct for this the procedure would have been for the clinician to either omit some implants from the guide or to reposition them slightly away from the foramen. Although the pt was not harmed the surgical intervention was not completed as intended due to malfunction of the product. As such, the event is reportable per 21 cfr part 803.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007362683-2014-00003 |
| MDR Report Key | 4380079 |
| Report Source | 05 |
| Date Received | 2014-12-31 |
| Date of Report | 2014-08-18 |
| Date Mfgr Received | 2014-08-18 |
| Date Added to Maude | 2015-01-06 |
| 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., 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 | REDUCTION GUIDE |
| Generic Name | VARIOUS |
| Product Code | EBG |
| Date Received | 2014-12-31 |
| Returned To Mfg | 2014-07-30 |
| Catalog Number | 54500227 |
| 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 | 2014-12-31 |