MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-01-07 for RELYX ULTIMATE ADHESIVE RESIN CEMENT 56890 manufactured by 3m Deutschland Gmbh.
[35294931]
Since this event involved three medical devices, three manufacturer reports are being submitted. Manufacturer report numbers 3005174370-2016-00001 and 9611385-2016-00002 describe the first and third device, respectively.
Patient Sequence No: 1, Text Type: N, H10
[35294932]
On (b)(6) 2015, a dental professional informed 3m about a patient who required tooth extraction. This patient had a 3m espe lava ultimate cad/cam restorative for cerec crown secured with 3m espe relyx ultimate adhesive resin cement and 3m espe scotchbond universal adhesive. The patient, a (b)(6) year old female patient, received the lava ultimate crown on tooth #19 on (b)(6) 2013. Patient was examined on (b)(6) 2015, and bitewing x-rays showed no evidence of any problem. Patient contacted the office on (b)(6) 2015, reporting that the area around the crown was painful. Patient called again on (b)(6) 2015, to report that she was in constant pain and that her face was swelling. Bitewing and pa x-rays taken at this time showed evidence of extreme decay. The patient was referred to a periodontist who performed tooth extraction and bone grafting on (b)(6) 2015. Patient is reported to be healing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611385-2016-00001 |
| MDR Report Key | 5351830 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-01-07 |
| Date of Report | 2015-11-10 |
| Date Mfgr Received | 2015-11-10 |
| Date Added to Maude | 2016-01-07 |
| 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 | DR. THOMAS MEINDL |
| Manufacturer Street | CARL-SCHURZ-STRABE 1 |
| Manufacturer City | NEUSS, 41453 |
| Manufacturer Country | GM |
| Manufacturer Postal | 41453 |
| Manufacturer G1 | 3M DEUTSCHLAND GMBH-SEEFELD |
| Manufacturer Street | ESPE PLATZ |
| Manufacturer City | SEEFELD, D82229 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D82229 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RELYX ULTIMATE ADHESIVE RESIN CEMENT |
| Generic Name | DENTAL CEMENT |
| Product Code | EMA |
| Date Received | 2016-01-07 |
| Catalog Number | 56890 |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M DEUTSCHLAND GMBH |
| Manufacturer Address | CARL-SCHURZ-STRABE 1 NEUSS, 41453 GM 41453 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-01-07 |