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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB FLANGE FIXTURE ST 3MM W. BAHA ABUTMENT; COCHLEAR BAHA CONNECT SYSTEM
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COCHLEAR BONE ANCHORED SOLUTIONS AB FLANGE FIXTURE ST 3MM W. BAHA ABUTMENT; COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 90480
Medical Device Problem Code Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code Host-Tissue Reaction (1297)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This report is submitted on january 11, 2018, by cochlear ltd.On behalf of cochlear americas.(b)(4).
 
Event or Problem Description
Per the clinic, the patient experienced skin overgrowth at abutment site and subsequently was treated with a topical steroid (date not reported).
 
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Brand Name
FLANGE FIXTURE ST 3MM W. BAHA ABUTMENT
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 Key7181061
Report Number6000034-2018-00049
Device Sequence Number16482606
Product Code LXB
UDI-Device Identifier09321502014298
UDI-Public(01)09321502014298
Combination Product (Y/N)N
PMA/510(K) Number
K955713
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2008
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Patient
Type of Report Initial
Report Date (Section B) 12/19/2017
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 Number90480
Device Catalogue Number90480
Device Lot Number602680
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 12/19/2017
Initial Report FDA Received Date01/10/2018
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;
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