MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-12-05 for BONEBRIDGE BCI BONE CONDUCTION IMPLANT manufactured by Med-el Elektromedizinische Geraete Gmbh.
[129379455]
Based on the currently available information, a mechanical damage to the implant due to the reported external impact appears likely. However, to determine and confirm an exact root cause of failure a device investigation at the explanted device is necessary. Re-implantation is scheduled for (b)(6) 2019. This is a combined initial and final report.
Patient Sequence No: 1, Text Type: N, H10
[129379456]
According to the surgeon the device was damaged following a trauma. Prior to this event the device was being used without any problems. Re-implantation is scheduled for (b)(6) 2019, and there is no planned appointment before this date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710014-2018-00976 |
| MDR Report Key | 8132136 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-12-05 |
| Date of Report | 2018-12-05 |
| Date Mfgr Received | 2018-11-29 |
| Date Added to Maude | 2018-12-05 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LAURA SIMONOTTI |
| Manufacturer Street | FUERSTENWEG 77A |
| Manufacturer City | INNSBRUCK 6020 |
| Manufacturer Country | AU |
| Manufacturer Postal | 6020 |
| Manufacturer Phone | 57788 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BONEBRIDGE |
| Generic Name | BCI BONE CONDUCTION IMPLANT |
| Product Code | PFO |
| Date Received | 2018-12-05 |
| Model Number | BCI BONE CONDUCTION IMPLANT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH |
| Manufacturer Address | INNSBRUCK AU |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-05 |