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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIA300 IMPLANT 3MM W ABUTMENT 6MM; COCHLEAR BAHA CONNECT SYSTEM
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COCHLEAR BONE ANCHORED SOLUTIONS AB BIA300 IMPLANT 3MM W ABUTMENT 6MM; COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 92126
Medical Device Problem Code Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code Pain (1994)
Date of Event 01/05/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This report is submitted january 25, 2018, (b)(4).
 
Event or Problem Description
Per the clinic, the patient experienced pain at abutment site however the issue could not be resolved.Subsequently on (b)(6) 2018, the patient was placed under general anesthesia to remove the abutment.The implanted device remains.
 
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Brand Name
BIA300 IMPLANT 3MM W ABUTMENT 6MM
Common Device Name
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 Key7217376
Report Number6000034-2018-00167
Device Sequence Number13706718
Product Code LXB
UDI-Device Identifier09321502019514
UDI-Public(01)09321502019514
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
K100360
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2012
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Health Professional
Type of Report Initial
Report Date (Section B) 01/10/2018
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
Operator of Device Lay User/Patient
Device Model Number92126
Device Catalogue Number92126
Device Lot Number82070
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 01/10/2018
Initial Report FDA Received Date01/24/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age34 YR
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