BIA400 IMPLANT 4MM W ABUTMENT 10MM 93331

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-16 for BIA400 IMPLANT 4MM W ABUTMENT 10MM 93331 manufactured by Cochlear Bone Anchored Solutions Ab.

Event Text Entries

[183611997] This report is submitted on march 16, 2020.
Patient Sequence No: 1, Text Type: N, H10


[183611998] Per the clinic, there was a loss of implant osseointegration shortly after the initial implant. The patient was not reimplanted with a new device.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number6000034-2020-00714
MDR Report Key9838159
Date Received2020-03-16
Date of Report2020-02-19
Report Date2020-03-16
Date Reported to FDA2020-03-16
Date Reported to Mfgr2020-02-19
Date Mfgr Received2020-02-19
Device Manufacturer Date2019-06-12
Date Added to Maude2020-03-16
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
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBIA400 IMPLANT 4MM W ABUTMENT 10MM
Generic NameCOCHLEAR BAHA CONNECT SYSTEM
Product CodeMAH
Date Received2020-03-16
Model Number93331
Catalog Number93331
Lot NumberCOH1311016
OperatorLAY USER/PATIENT
Device AvailabilityN
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 2020-03-16

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