FLANGE FIXTURE ST 4MM 90432

MAUDE Adverse Event Report

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 FLANGE FIXTURE ST 4MM 90432 manufactured by Cochlear Bone Anchored Solutions Ab.

Event Text Entries

[185969055] 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


[185969056] 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


MAUDE Entry Details

Report Number6000034-2020-00947
MDR Report Key9881619
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-25
Date of Report2020-03-02
Date of Event2020-01-27
Date Mfgr Received2020-03-02
Date Added to Maude2020-03-25
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMRS BIANCA PRIES
Manufacturer Street1 UNIVERSITY AVENUE
Manufacturer CityMACQUARIE UNIVERSITY, NSW 2109
Manufacturer CountryAS
Manufacturer Postal2109
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFLANGE FIXTURE ST 4MM
Generic NameCOCHLEAR BAHA CONNECT SYSTEM
Product CodeLXB
Date Received2020-03-25
Returned To Mfg2020-03-06
Model Number90432
Catalog Number90432
Lot NumberNI
OperatorLAY USER/PATIENT
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerCOCHLEAR BONE ANCHORED SOLUTIONS AB
Manufacturer AddressKONSTRUKTIONSV?GEN 14 PO BOX 82 M?LNLYCKE, 435 22 SW 435 22


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-25

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