MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-25 for FLANGE FIXTURE ST 4MM 90432 manufactured by Cochlear Bone Anchored Solutions Ab.
[185970443]
Per the clinic, it was reported that the patient experienced a loss of osseointegration resulting in fixture loss on (b)(6) 2020. 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 | 6000034-2020-00948 |
| MDR Report Key | 9881618 |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-02 |
| Date of Event | 2020-01-27 |
| Date Facility Aware | 2020-03-02 |
| Report Date | 2020-03-26 |
| Date Reported to FDA | 2020-03-26 |
| Date Reported to Mfgr | 2020-03-26 |
| Date Added to Maude | 2020-03-25 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| 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 |
| Generic Name | COCHLEAR BAHA CONNECT SYSTEM |
| Product Code | LXB |
| Date Received | 2020-03-25 |
| Returned To Mfg | 2020-03-06 |
| Model Number | 90432 |
| Catalog Number | 90432 |
| Lot Number | NI |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| 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 | 2020-03-25 |