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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 ATTRACT SYSTEM
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COCHLEAR BONE ANCHORED SOLUTIONS AB BIM400 IMPLANT MAGNET; COCHLEAR BAHA ATTRACT SYSTEM Back to Search Results
Model Number 93550
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Headache (1880)
Event Date 05/11/2021
Event Type  Injury  
Event Description
Per the surgeon, the patient underwent revision surgery on (b)(6) 2021, in order to convert the patient to a percutaneous baha implant system due to headaches.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 ATTRACT SYSTEM
Manufacturer (Section D)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
po box 82
mölnlycke, 435 2 2
SW  435 22
MDR Report Key11936583
MDR Text Key254269346
Report Number6000034-2021-01623
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
Type of Report Initial
Report Date 06/04/2021,05/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date11/30/2019
Device Model Number93550
Device Catalogue Number93550
Device Lot Number98544
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/04/2021
Distributor Facility Aware Date05/15/2021
Event Location Hospital
Date Report to Manufacturer06/04/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/03/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age61 YR
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