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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 No Code Available (3191)
Event Date 05/21/2020
Event Type  Injury  
Manufacturer Narrative
This report is submitted on june 23, 2020.
 
Event Description
Per the surgeon, the patient had previous issues during mris.The patient underwent revision surgery on (b)(6) 2020, in order to convert the patient to a percutaneous baha implant system.During the procedure, the internal magnet was removed and an abutment was placed on the internal fixture.
 
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Brand Name
BI300 IMPLANT 4 MM
Type of Device
COCHLEAR BAHA CONNECT SYSTEM
Manufacturer (Section D)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
po box 82
mölnlycke, 435 2 2
SW  435 22
MDR Report Key10182663
MDR Text Key196055869
Report Number6000034-2020-01551
Device Sequence Number1
Product Code LXB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K100360
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Physician
Type of Report Initial
Report Date 06/23/2020,06/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/23/2020
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/23/2020
Date Report to Manufacturer06/02/2020
Date Manufacturer Received06/02/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age56 YR
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