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.
[71682348]
This manufacturer report is being submitted for the first of four individual patient cases identified in manufacturing report 3005174370-2016-00040 follow-up 1. 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 tooth extraction.
Patient Sequence No: 1, Text Type: N, H10
[71682349]
This patient record was identified during post-market surveillance activities. Records supplied by the dental office indicate that a female patient (yob 1966) required extraction of tooth #30. This tooth had received a lava ultimate crown on (b)(6), 2012, because a prior crown had broken and was painful. On (b)(6) 2013, this tooth received root canal therapy (because the tooth was reported as "having throbbing pain" from the date of seating, a relationship to the use of lava ultimate is not established. The onset of symptoms at seating suggests that either pre-existing conditions or preparation trauma led to the need for the root canal. ) after the root canal, the same lava ultimate crown was re-seated. On (b)(6) 2015, the patient reported that the crown had debonded 3 days prior; she was experiencing some sensitivity and a periapical x-ray showed evidence of infection around the root. On (b)(6) 2015, an endodontist recommended that the tooth be extracted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005174370-2017-00029 |
| MDR Report Key | 6457821 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-04-04 |
| Date of Report | 2017-03-08 |
| Date of Event | 2015-07-10 |
| 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 |