MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-19 for DT LIGHT SL POST V041931000003 manufactured by Recherches Techniques Dentaires (r.t.d.).
[139290606]
Because this event resulted in a serious injury, 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. There cannot made an explicit root cause. A dhr review was conducted with no discrepancies noted. This submission is being made after an acquisition and internal audit of rtd.
Patient Sequence No: 1, Text Type: N, H10
[139290607]
In this event it was reported that a dt light post fractured. The tooth was extracted and customer got an implant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3001226627-2016-00004 |
| MDR Report Key | 8434548 |
| Date Received | 2019-03-19 |
| Date of Report | 2019-03-19 |
| Date Mfgr Received | 2016-08-04 |
| Date Added to Maude | 2019-03-19 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. KARL NITTINGER |
| Manufacturer Street | 221 W. PHILADELPHIA ST. SUITE 60W |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178494424 |
| Manufacturer G1 | RECHERCHES TECHNIQUES DENTAIRES (R.T.D.) |
| Manufacturer Street | 3 RUE LOUIS NEEL |
| Manufacturer City | ST. EGREVE ISERE, 38120 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 38120 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DT LIGHT SL POST |
| Generic Name | POST, ROOT CANAL |
| Product Code | ELR |
| Date Received | 2019-03-19 |
| Model Number | NA |
| Catalog Number | V041931000003 |
| Lot Number | 111869 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RECHERCHES TECHNIQUES DENTAIRES (R.T.D.) |
| Manufacturer Address | 3 RUE LOUIS NEEL ST. EGREVE ISERE, 38120 FR 38120 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2019-03-19 |