MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-09-29 for SURGIGUIDE 37502 manufactured by Dentsply Implants N.v..
[55943608]
Since this event resulted in the need for 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. We discovered that the implant library had the surgical axis placement of the implant matched to the restorative/abutment axis, thereby misaligning the actual surgical placement axis. Until this issue has been rectified in our library we will block all orders with these specific angulated implants. We will correct this mistake in our next library release ((b)(6) 2016).
Patient Sequence No: 1, Text Type: N, H10
[55943609]
A customer used a surgiguide to create the osteotomy for two keystone dental implants on tooth position #7 and #10. The central axis of the osteotomy for both implants did deviate 12 degrees to the buccal side from the original planning. The incorrect implant placement leads to the fact that the apical part of both implants are perforating the buccal plate and need grafting or the implants need to be removed and replaced during a second corrective surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007362683-2016-00011 |
| MDR Report Key | 5987398 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-09-29 |
| Date of Report | 2016-08-30 |
| Date of Event | 2016-07-19 |
| Date Mfgr Received | 2016-08-30 |
| Date Added to Maude | 2016-09-29 |
| 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 | 2016-09-29 |
| Model Number | NA |
| Catalog Number | 37502 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | 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 | 2016-09-29 |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Product Code | EBG |
| Date Received | 2016-09-29 |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-09-29 |