BIA400 IMPLANT 4MM W ABUTMENT 12MM 93332

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-12 for BIA400 IMPLANT 4MM W ABUTMENT 12MM 93332 manufactured by Cochlear Bone Anchored Solutions Ab.

Event Text Entries

[183240077] This report is submitted on 13 march 2020.
Patient Sequence No: 1, Text Type: N, H10


[183240078] Per the clinic, the patient experienced a loss of osseointegration. It is unknown if there are plans to re-implant the patient with a new device as of the date of this report.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number6000034-2020-00680
MDR Report Key9827089
Date Received2020-03-12
Date of Report2020-02-17
Date Facility Aware2020-02-17
Report Date2020-03-13
Date Reported to FDA2020-03-13
Date Added to Maude2020-03-12
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBIA400 IMPLANT 4MM W ABUTMENT 12MM
Generic NameCOCHLEAR BAHA CONNECT SYSTEM
Product CodeMAH
Date Received2020-03-12
Model Number93332
Catalog Number93332
Lot NumberCOH1291728
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by Mfgr*
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 2020-03-12

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