MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-10 for CEMENT USED FOR DENTAL IMPLANT manufactured by Unk.
[117129843]
On date above i was examined by an oral surgeon relating to inflammation at site of an existing dental implant. After dr's review or imaging, i was informed that there was bone loss, believed to have been caused by cement used to attach the crown to the abutment, at the site of two implants. Further, there is a possibility of bone loss to two add'l adjacent teeth. Is there anything i can do? I am afraid that my dental insurance might not cover the removal, restoration, and re-do. I waited for over two years for reimbursement on the last (unrelated) implant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5079078 |
| MDR Report Key | 7776785 |
| Date Received | 2018-08-10 |
| Date of Report | 2018-08-09 |
| Date of Event | 2018-08-06 |
| Date Added to Maude | 2018-08-13 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CEMENT USED FOR DENTAL IMPLANT |
| Generic Name | CEMENT, DENTAL |
| Product Code | EMA |
| Date Received | 2018-08-10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-08-10 |