SUPERLINE Adverse Event — Injury (MDR 3005503242-2020-00062)
SUPERLINE Adverse Event — Injury (MDR 3005503242-2020-00062) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: SUPERLINE; Generic name: DENTAL IMPLANT; Manufacturer: DENTIUMUSA.
| Device | SUPERLINE |
|---|---|
| Generic name | DENTAL IMPLANT |
| Manufacturer | DENTIUMUSA |
| Report number | 3005503242-2020-00062 |
| Event type | Injury |
| Product problem | N |
| Date received | 2020-04-28 |
| Report source | HEALTH PROFESSIONAL |
| Narrative | THE DENTAL IMPLANT FX4508SWC WAS REMOVED ON (B)(6) 2019 DUE TO LOSS OF OSSEOINTEGRATION AROUND 3 YEARS AND 8 MONTHS AFTER IMPLANTATION. THE PATIENT HAS HISTORY OF DIABETES. THE PATIENT REQUIRED BONE AUGMENTATION FOR THE OPERATION. THE DOCTOR NOTED PERIODONTAL DISEASE DURING EXPLANTATION. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS. |
| Source | openFDA MAUDE (device adverse events) |
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