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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIM400 IMPLANT MAGNET; COCHLEAR BAHA CONNECT SYSTEM
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COCHLEAR BONE ANCHORED SOLUTIONS AB BIM400 IMPLANT MAGNET; COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 93550
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 09/13/2019
Event Type  Injury  
Event Description
Per the clinic, the patient underwent revision surgery on (b)(6) 2019, in order to convert the patient to a percutaneous baha implant system due to retention issues.During the procedure, the internal magnet was removed and an abutment was placed on the internal fixture.
 
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Brand Name
BIM400 IMPLANT MAGNET
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 Key9253862
MDR Text Key164829870
Report Number6000034-2019-02197
Device Sequence Number1
Product Code LXB
UDI-Device Identifier09321502025294
UDI-Public(01)09321502025294(10)98544(17)191130
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/30/2019,10/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/29/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number93550
Device Catalogue Number93550
Device Lot Number98544
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/10/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/30/2019
Event Location Hospital
Date Report to Manufacturer10/30/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age12 YR
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