MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-16 for SURGIGUIDE 37502 manufactured by Dentsply Implants N.v..
[55002893]
Since this event resulted in medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, it must be presumed that the malfunction would be likely to cause or contribute to a serious injury should it recur. As such, this event meets the definition of a reportable event per 21 cfr part 803. The device is available for evaluation, though results are not available as of this report. Evaluation results will be submitted as they become available.
Patient Sequence No: 1, Text Type: N, H10
[55002894]
It was reported that a surgiguide was used to create the osteotomy for two dental implants (tooth position 7 and 10). After the first drilling step the surgical guide was removed to complete the additional drilling steps free handed according to the pilot guide drilling protocol. After placing the implants free handed, the customer discovered that the implant in #7 was positioned correctly but the implant in #10 was positioned too distal. A second surgery is needed to correct the positioning of implant in #10.
Patient Sequence No: 1, Text Type: D, B5
[58618540]
We have reviewed the matching of the plaster model onto the ct images carefully and we could confirm that the matching is optimal. We received notes indicating that the doctor had positioned the implant on position 10 in the middle of the edentulous space. We however noticed that this was not managed properly. As the implant position goes more distal as expected, it might be that there was a perception issue during the planning. Suggested to consider the use of a fully-guided implant safe guide to have a full sequenced drill and implant guidance.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007362683-2016-00010 |
| MDR Report Key | 5958449 |
| Date Received | 2016-09-16 |
| Date of Report | 2016-08-19 |
| Date Mfgr Received | 2016-09-27 |
| Date Added to Maude | 2016-09-16 |
| 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 | 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SURGIGUIDE |
| Generic Name | SYSTEM, IMAGE PROCESSING, RADIOLOGICAL |
| Product Code | LLZ |
| Date Received | 2016-09-16 |
| Returned To Mfg | 2016-08-19 |
| Model Number | NA |
| Catalog Number | 37502 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2016-09-16 |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Product Code | EBG |
| Date Received | 2016-09-16 |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-09-16 |