MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-07-15 for SURGIGUIDE 37501 manufactured by Dentsply Implants N.v..
[49743766]
There has been a previous report received where this malfunction resulted in a serious injury. Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such. As such, this event is reportable per 21cfr part 803. The device was evaluated and found to meet specification. The customer provided an outdated model for the guide design.
Patient Sequence No: 1, Text Type: N, H10
[49743767]
It was reported that a surgiguide did not properly fit in a patient's mouth. The dental implant placement surgery has been delayed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007362683-2016-00006 |
| MDR Report Key | 5799067 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-07-15 |
| Date of Report | 2016-06-16 |
| Date of Event | 2016-05-31 |
| Date Mfgr Received | 2016-06-16 |
| Date Added to Maude | 2016-07-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | MRS. HELEN LEWIS |
| Manufacturer Street | 221 W. PHILADELPHIA ST. SUITE 60W |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178494229 |
| Manufacturer G1 | DENTSPLY IMPLANTS N.V. |
| Manufacturer Street | RESEARCH CAMPUS 10 |
| Manufacturer City | HASSELT LIMBURG, B-3500 |
| Manufacturer Country | BE |
| Manufacturer Postal Code | B-3500 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SURGIGUIDE |
| Generic Name | SYSTEM, IMAGE PROCESSING, RADIOLOGICAL |
| Product Code | LLZ |
| Date Received | 2016-07-15 |
| Returned To Mfg | 2016-06-15 |
| Model Number | NA |
| Catalog Number | 37501 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY IMPLANTS N.V. |
| Manufacturer Address | RESEARCH CAMPUS 10 HASSELT LIMBURG, B-3500 BE B-3500 |
| Product Code | DZE |
| Date Received | 2016-07-15 |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Product Code | EBG |
| Date Received | 2016-07-15 |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-07-15 |