MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-12-03 for SICAT ACCESSGUIDE 1060110 manufactured by Sicat Gmbh & Co. Kg.
[129060511]
The dentist suspected that the two endodontic guides were not manufactured according to prescription/planning. The dentist has returned the suspected sicat accessguide(s) back to sicat for evaluation. Before initial shipment of the guides to the dentist, the sleeve positions and orientations had been verified at sicat surgical guides lab using a coordinate measurement machine. The final protocol of this procedure has been reevaluated. The protocol does not show any relevant deviation of the actual sleeve positions and angulations within the guides compared to the doctors planning of sleeve position and angulation. The returned sicat acessguide(s) were evaluated using a 3d printed model of the patients jaw. The seating of the guides is stable. The access holes are in the occlusion at the positions and angulations planned by the dentist. The inspection does not give any indication for an incorrect arrangement of the sleeves or of any other device problem.
Patient Sequence No: 1, Text Type: N, H10
[129060512]
The reporting dentist has used a sicat acessguide for preparing access canals for two root canals of tooth #4. However, the drillings were more distal for the buccal canal than he planned and the access hole for the lingual canal was also too far distal. The root canal could not be found. The tooth had to be extracted. Remark: the sicat acessguide consists of two separate guides, one guide for each access canal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006098230-2018-00007 |
| MDR Report Key | 8124824 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-12-03 |
| Date of Report | 2018-12-03 |
| Date of Event | 2018-11-05 |
| Date Mfgr Received | 2018-11-05 |
| Device Manufacturer Date | 2018-10-29 |
| Date Added to Maude | 2018-12-03 |
| 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 | DR. MANFRED BREUER |
| Manufacturer Street | BRUNNENALLEE 6 |
| Manufacturer City | BONN, NRW 53177 |
| Manufacturer Country | GM |
| Manufacturer Postal | 53177 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SICAT ACCESSGUIDE |
| Generic Name | ENDODONTIC GUIDE; ACCESSORY TO DENTAL BUR |
| Product Code | EJL |
| Date Received | 2018-12-03 |
| Returned To Mfg | 2018-11-08 |
| Catalog Number | 1060110 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SICAT GMBH & CO. KG |
| Manufacturer Address | BRUNNENALLEE 6 BONN, NRW 53177 GM 53177 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-12-03 |