MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-17 for BIA300 IMPLANT 4MM W ABUTMENT 6MM 92127 manufactured by Cochlear Bone Anchored Solutions Ab.
[183695987]
This report is submitted on 17 march 2020.
Patient Sequence No: 1, Text Type: N, H10
[183695989]
Per the clinic, the patient experienced a loss of osseointegration resulting in fixture loss. Re-implantation is planned but has not taken place as of the date of this report.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 6000034-2020-00704 |
MDR Report Key | 9838601 |
Report Source | HEALTH PROFESSIONAL |
Date Received | 2020-03-17 |
Date of Report | 2020-02-19 |
Date Mfgr Received | 2020-02-19 |
Date Added to Maude | 2020-03-17 |
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 | BIA300 IMPLANT 4MM W ABUTMENT 6MM |
Generic Name | COCHLEAR BAHA CONNECT SYSTEM |
Product Code | LXB |
Date Received | 2020-03-17 |
Returned To Mfg | 2020-02-19 |
Model Number | 92127 |
Catalog Number | 92127 |
Operator | LAY USER/PATIENT |
Device Availability | R |
Device Eval'ed by Mfgr | N |
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 | 2020-03-17 |