MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-11-19 for COCHLEAR? VISTAFIX? VXA300 ABUTMENT 6MM 92996 manufactured by Cochlear Bone Anchored Solutions Ab.
[127846373]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[127846374]
Per the clinic, the patient developed infections and experienced pain and lack of clinical benefit with abutment use. Subsequently, the abutment was removed (date not reported).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000034-2018-02273 |
| MDR Report Key | 8087980 |
| Report Source | USER FACILITY |
| Date Received | 2018-11-19 |
| Date of Report | 2018-11-13 |
| Date Mfgr Received | 2018-11-13 |
| Date Added to Maude | 2018-11-19 |
| 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. TAMARA MARTIN |
| Manufacturer Street | 1 UNIVERSITY AVENUE |
| Manufacturer City | MACQUARIE UNIVERSITY, NSW 2109 |
| Manufacturer Country | AS |
| Manufacturer Postal | 2109 |
| Manufacturer G1 | COCHLEAR BONE ANCHORED SOLUTIONS AB |
| Manufacturer Street | KONSTRUKTIONSV PO BOX 82 |
| Manufacturer City | M 43533 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | 43533 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COCHLEAR? VISTAFIX? VXA300 ABUTMENT 6MM |
| Generic Name | COCHLEAR BAHA CONNECT SYSTEM |
| Product Code | FZE |
| Date Received | 2018-11-19 |
| Model Number | 92996 |
| Catalog Number | 92996 |
| Lot Number | ASKU |
| 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 | 2018-11-19 |