MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-03-19 for DT LIGHT POST V040931000002 manufactured by Recherches Techniques Dentaires (r.t.d.).
[139320160]
While no serious injury was reported, there has been a previous report received where breakage resulted in a serious injury. Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such. As such, this event is reportable per 21cfr part 803. Fiber reinforced composite material does not bend after breaking, it is not a fragile material for breakage. After breakage, it remains in place. But if repeated forces are applied then some pieces of the material would lose and some other would continue resisting. It is like a fatigue. In that case, it would come from a loosening, debonding. But not at the beginning, with the time being, the post/restoration starts a little bit and then progressively increases while loading forces continue applying. Root cause could be debonding or losing of sealing ability. This submission is being made after an acquisition and internal audit of rtd.
Patient Sequence No: 1, Text Type: N, H10
[139320161]
In this event it was reported that a dt light post fractured. The patient has got a new post.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3001226627-2017-00001 |
| MDR Report Key | 8434545 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-03-19 |
| Date of Report | 2019-03-19 |
| Date Mfgr Received | 2017-07-26 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 POST |
| Generic Name | POST, ROOT CANAL |
| Product Code | ELR |
| Date Received | 2019-03-19 |
| Returned To Mfg | 2017-08-30 |
| Model Number | NA |
| Catalog Number | V040931000002 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2019-03-19 |