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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BI300 IMPLANT 3MM; COCHLEAR BAHA CONNECT SYSTEM
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COCHLEAR BONE ANCHORED SOLUTIONS AB BI300 IMPLANT 3MM; COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 92128
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Injury  
Event Description
Per the clinic, the main implant was explanted (specific reason and date not reported).The patient was reimplanted with another cochlear device during the same surgery.
 
Event Description
Per the clinic, the device was explanted due to an infection.The patient was treated with antibiotics (date, duration and type not reported), however, the issue did not resolve.
 
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Brand Name
BI300 IMPLANT 3MM
Type of Device
COCHLEAR BAHA CONNECT SYSTEM
Manufacturer (Section D)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
po box 82
mölnlycke, 435 3 3
SW  435 33
MDR Report Key12187152
MDR Text Key262152530
Report Number6000034-2021-02200
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 11/12/2021,10/25/2021
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 Model Number92128
Device Catalogue Number92128
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/24/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/12/2021
Distributor Facility Aware Date10/25/2021
Event Location Hospital
Date Report to Manufacturer11/12/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/19/2021
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received11/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient SexMale
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