MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-25 for BI300 IMPLANT 3MM 92128 manufactured by Cochlear Bone Anchored Solutions Ab.
[185952904]
The reported adverse is associated with a returned device; however, the provided clinical information was reviewed by the manufacturer and no specific device analysis is deemed necessary at this time. Previous product examinations have not showed any relationship between a product geometrical deviation and the reported clinical complication. Additionally, there are no indications that a product failure has contributed to the reported issue. Implant loss with baha implants can occur at any time following implantation. Known reasons for implant loss include lack of adequate bone quality/quantity, trauma, infection, generalised diseases and surgical complication. The report frequency for these complications is being monitored under cbas complaint and medical device reporting data monitoring plan and the status is updated on a monthly basis. This event is added to this monitoring. This report is submitted on march 26, 2020.
Patient Sequence No: 1, Text Type: N, H10
[185952905]
Per the clinic, it was reported that the patient experienced a lack of osseointegration resulting in fixture loss due to compromised bone and localised site granulation. The patient was treated with topical medication following the fixture loss (type not reported). It is unknown whether there are plans to reimplant the patient, as of the date of this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000034-2020-00932 |
| MDR Report Key | 9881579 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-02 |
| Date Mfgr Received | 2020-03-02 |
| Date Added to Maude | 2020-03-25 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS BIANCA PRIES |
| 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 | BI300 IMPLANT 3MM |
| Generic Name | COCHLEAR BAHA CONNECT SYSTEM |
| Product Code | LXB |
| Date Received | 2020-03-25 |
| Returned To Mfg | 2020-03-12 |
| Model Number | 92128 |
| Catalog Number | 92128 |
| Lot Number | NI |
| 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 | 2020-03-25 |