MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-01-24 for COCHLEAR? VISTAFIX? VXI300 IMPLANT 4MM 93101 manufactured by Cochlear Bone Anchored Solutions Ab.
[98043566]
This report is submitted on january 24, 2018. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[98043567]
It was reported that the patient experienced a loss of osseointegration subsequent to the patient experiencing pain and secretion at the abutment site. The device was explanted and the patient was treated with antibiotics.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000034-2018-00251 |
| MDR Report Key | 7214567 |
| Report Source | USER FACILITY |
| Date Received | 2018-01-24 |
| Date of Report | 2018-01-12 |
| Date Mfgr Received | 2018-01-12 |
| Date Added to Maude | 2018-01-24 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. SUJEEWA WIJESINGHE |
| 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 ATTRACT SYSTEM |
| Product Code | FZE |
| Date Received | 2018-01-24 |
| Model Number | 93101 |
| Catalog Number | 93101 |
| Lot Number | 158224 |
| 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 | 2018-01-24 |