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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB ASKU; COCHLEAR BAHA CONNECT SYSTEM
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COCHLEAR BONE ANCHORED SOLUTIONS AB ASKU; COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number ASKU
Device Problems Loss of Osseointegration (2408); Patient Device Interaction Problem (4001)
Patient Problems Inadequate Osseointegration (2646); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 05/25/2023
Event Type  Injury  
Event Description
Per the clinic, the implant site was debrided with hydrogen peroxide on (b)(6) 2023.Additional information has been requested but has not been made available as of the date of this report.
 
Event Description
Per the clinic, the patient experienced a loss of osseointegration resulting in fixture loss (specific date not reported).Subsequently, the patient was treated with oral and topical antibiotics (specific date and duration not reported).
 
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Brand Name
ASKU
Type of Device
COCHLEAR BAHA CONNECT SYSTEM
Manufacturer (Section D)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
mölnlycke, 435 3 3
SW  435 33
MDR Report Key17376590
MDR Text Key319648999
Report Number6000034-2023-02349
Device Sequence Number1
Product Code LXB
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,Followup
Report Date 08/29/2023,08/07/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/24/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberASKU
Device Catalogue NumberASKU
Device Lot NumberASKU
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/29/2023
Distributor Facility Aware Date08/07/2023
Date Report to Manufacturer08/07/2023
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age66 YR
Patient SexFemale
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