MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-18 for HENRY SCHEIN 100-7775 manufactured by Harald Nordin S.a..
[57780040]
Customer reports that a gold plated screw post broke while screwing the post inside the root canal during a dental restoration crown build up procedure on a patient. The procedure was performed without any particular torque force when the post broke without the possibility to remove it from the root canal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2411236-2016-00005 |
| MDR Report Key | 6037928 |
| Date Received | 2016-10-18 |
| Date of Report | 2016-09-19 |
| Date of Event | 2016-09-12 |
| Date Facility Aware | 2016-09-19 |
| Report Date | 2016-10-18 |
| Date Reported to FDA | 2016-10-18 |
| Date Reported to Mfgr | 2016-10-18 |
| Date Added to Maude | 2016-10-18 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HENRY SCHEIN |
| Generic Name | SCREW POST GOLD PLATED |
| Product Code | ELR |
| Date Received | 2016-10-18 |
| Catalog Number | 100-7775 |
| Lot Number | 15732 |
| Operator | DENTIST |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HARALD NORDIN S.A. |
| Manufacturer Address | Z.I. LA FOGE 12 CHAILLY SUR MONTREUX, VAUD, CH-1816 SZ CH-1816 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-10-18 |