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.
[71620811]
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
[71620812]
This patient record was identified during post-market surveillance activities. Records supplied by the dental office indicate that a male patient ((b)(6)) required root canal therapy on tooth #3. This tooth had received a lava ultimate crown on (b)(6) 2014, because recurrent decay had occurred beneath a prior temporary crown; details on when the temporary crown was placed were not provided. On (b)(6) 2014, the lava ultimate crown debonded and was re-cemented. On (b)(6) 2014, the crown fractured and a new lava ultimate crown was placed. Records indicate that at this time, very little tooth structure remained; the dental professional noted that if the crown debonded again, it was possible that a root canal and core build-up might be necessary. On (b)(6) 2014, the lava ultimate crown debonded and was re-secured with a temporary cement. On (b)(6) 2014, a crack was identified in the tooth and patient was referred to endodontist for root canal (which was likely conducted on (b)(6) 2014). On (b)(6) 2014, a new non-3m crown was placed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005174370-2017-00028 |
| MDR Report Key | 6456833 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-04-04 |
| Date of Report | 2017-03-08 |
| 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 |