MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-09 for FLANGE FIXTURE ST 4MM W. BAHA ABUTMENT 90434 manufactured by Cochlear Bone Anchored Solutions Ab.
[182688003]
This report is submitted on 10 march 2020.
Patient Sequence No: 1, Text Type: N, H10
[182688004]
Per the clinic, the patient experienced a loss of osseointegration, subsequently the patient underwent revision surgery on (b)(6) 2020, in order to have a magnet placed on the internal fixture, converting the patient to a subcutaneous baha implant system.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000034-2020-00647 |
| MDR Report Key | 9809271 |
| Date Received | 2020-03-09 |
| Date of Report | 2020-02-12 |
| Date Facility Aware | 2020-02-12 |
| Report Date | 2020-03-10 |
| Date Reported to FDA | 2020-03-10 |
| Date Added to Maude | 2020-03-09 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLANGE FIXTURE ST 4MM W. BAHA ABUTMENT |
| Generic Name | COCHLEAR BAHA CONNECT SYSTEM |
| Product Code | LXB |
| Date Received | 2020-03-09 |
| Model Number | 90434 |
| Catalog Number | 90434 |
| Lot Number | 606518 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 2020-03-09 |