MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-04-12 for COCHLEAR? VISTAFIX? VXI300 IMPLANT 4MM 93101 manufactured by Cochlear Bone Anchored Solutions Ab.
[141722020]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[141722021]
Per the clinic, the patient experienced a loss of osseointegration (date not reported). It is unknown if there are plans to re-implant the patient with a new device as of the date of this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000034-2019-00543 |
| MDR Report Key | 8507507 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-04-12 |
| Date of Report | 2019-03-23 |
| Date Mfgr Received | 2019-03-23 |
| Date Added to Maude | 2019-04-12 |
| 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 | MS. KRISTEL KOHNE |
| Manufacturer Street | 1 UNIVERSITY AVENUE |
| Manufacturer City | MACQUARIE UNIVERSITY, NSW 2109, |
| Manufacturer Country | AS |
| Manufacturer Postal | 2109, |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COCHLEAR? VISTAFIX? VXI300 IMPLANT 4MM |
| Generic Name | COCHLEAR BAHA VISTAFIX SYSTEM |
| Product Code | FZE |
| Date Received | 2019-04-12 |
| Model Number | 93101 |
| Catalog Number | 93101 |
| Lot Number | COH1105153 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COCHLEAR BONE ANCHORED SOLUTIONS AB |
| Manufacturer Address | KONSTRUKTIONSV?GEN 14 PO BOX 82 M?LNLYCKE, 435 22 SW 435 22 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-04-12 |