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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 Problem Failure to Osseointegrate (1863)
Patient Problems Foreign Body Reaction (1868); Patient Problem/Medical Problem (2688)
Event Type  Injury  
Event Description
Per the clinic, it was reported that the patient experienced a lack of osseointegration resulting in fixture loss due to compromised bone and localised site granulation.The patient was treated with topical medication following the fixture loss (type not reported).It is unknown whether there are plans to reimplant the patient, as of the date of this report.
 
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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 2 2
SW  435 22
MDR Report Key9881578
MDR Text Key185952071
Report Number6000034-2020-00933
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 Health Care Professional
Type of Report Initial
Report Date 03/26/2020,03/02/2020
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 Manufacturer03/12/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/26/2020
Distributor Facility Aware Date03/02/2020
Event Location Hospital
Date Report to Manufacturer03/26/2020
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/25/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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