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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BI300 IMPLANT 4 MM COCHLEAR BAHA CONNECT SYSTEM

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COCHLEAR BONE ANCHORED SOLUTIONS AB BI300 IMPLANT 4 MM COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 92129
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Head Injury (1879)
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

Per the clinic, the patient experienced a loss of connection to the internal device subsequent to sustaining a head trauma that resulted in the magnet detaching from the implant. Surgery to replace the magnet has been scheduled however has not occurred as of the date of this report.

 
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Brand NameBI300 IMPLANT 4 MM
Type of DeviceCOCHLEAR BAHA CONNECT SYSTEM
Manufacturer (Section D)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
po box 82
mölnlycke, 435 2 2
SW 435 22
Manufacturer (Section G)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
po box 82
mölnlycke, 43533
SW 43533
Manufacturer Contact
tamara martin
1 university avenue
macqaurie university, nsw 2109
AS   2109
MDR Report Key8396679
MDR Text Key138066662
Report Number6000034-2019-00361
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
PMA/PMN NumberK100360
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Type of Report Initial,Followup
Report Date 03/21/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/06/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number92129
Device Catalogue Number92129
Device LOT NumberCOH1061304
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/21/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 03/06/2019 Patient Sequence Number: 1
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