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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BAHA; HEARING AID, BONE CONDUCTION
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COCHLEAR BONE ANCHORED SOLUTIONS AB BAHA; HEARING AID, BONE CONDUCTION Back to Search Results
Model Number 95204
Device Problems Device Appears to Trigger Rejection (1524); Output Problem (3005)
Patient Problems Autoimmune Disorder (1732); Hemorrhage/Bleeding (1888); Failure of Implant (1924); Pain (1994)
Event Date 06/21/2021
Event Type  Injury  
Event Description
My body rejected my baha cochlear device after 9 years of successful use.The titanium abutment was surgically implanted in (b)(6) 2012 on the left side of my skull.I used the baha device without incident until (b)(6) 2021 when the entire abutment was rejected from my skull along with bloody discharge and pain.Since the original implantation, i have developed several autoimmune diseases.Prior to the implantation i was only suffering from crohn's disease.There were no tests conducted as none would have been appropriate.My body simply rejected the device.My physician and i are curious as to whether this is a common occurrence with people with autoimmune disease--to reject titanium implants.Fda safety report id # (b)(4).
 
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Brand Name
BAHA
Type of Device
HEARING AID, BONE CONDUCTION
Manufacturer (Section D)
COCHLEAR BONE ANCHORED SOLUTIONS AB
MDR Report Key12225372
MDR Text Key263481705
Report NumberMW5102747
Device Sequence Number1
Product Code LXB
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 07/21/2021
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? Yes
Device Operator Lay User/Patient
Device Model Number95204
Device Catalogue Number95204
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/23/2021
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age70 YR
Patient Weight57
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