MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-04-04 for LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC 2914A2-LT manufactured by 3m Espe Dental Products.
[71620373]
Based on the available records, it is not clear what role, if any, the lava ultimate restoration, played in this event. Other factors, such as prior tooth history and dental treatments, may have played a role in the need for root canal therapy.
Patient Sequence No: 1, Text Type: N, H10
[71620374]
This patient record was identified during post-market surveillance activities. Records supplied by the dental office indicate that a male patient (year of birth 1961) required root canal therapy on tooth #4. This tooth had received a lava ultimate crown on (b)(6)2012; the reason this crown was needed was not explicitly documented in the patient records. Treatment notes from this same date do indicate that core build-up was necessary, suggesting that there may have been a prior restoration or significant decay. On (b)(6) 2013, the patient reported that the lava ultimate crown had debonded approximately 2 weeks prior; the patient reported minor sensitivity. The crown was re-cemented. On (b)(6) 2015, the patient reported pain, which was traced to originating from tooth #4; diagnosis was necrotic root tissue and the recommendation for a root canal was made. The root canal was conducted on (b)(6) 2015, at which time, decay beneath the crown was identified. A new, non-3m crown was placed, along with core build-up and pins.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005174370-2017-00027 |
| MDR Report Key | 6456823 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-04-04 |
| Date of Report | 2017-03-08 |
| Date of Event | 2015-12-10 |
| Date Mfgr Received | 2017-03-08 |
| Date Added to Maude | 2017-04-04 |
| 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 | ANGIE DRAPER |
| Manufacturer Street | 2510 CONWAY AVENUE |
| Manufacturer City | ST. PAUL MN 551441000 |
| Manufacturer Country | US |
| Manufacturer Postal | 551441000 |
| Manufacturer G1 | 3M ESPE DENTAL PRODUCTS-IRVINE |
| Manufacturer Street | 2111 MCGAW AVENUE |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92614 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | Z-2052-2015 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC |
| Generic Name | MATERIAL, TOOTH SHADE, RESIN |
| Product Code | EBF |
| Date Received | 2017-04-04 |
| Catalog Number | 2914A2-LT |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M ESPE DENTAL PRODUCTS |
| Manufacturer Address | 2510 CONWAY AVENUE ST. PAUL MN 551441000 US 551441000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-04-04 |