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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB FLANGE FIXTURE AND ABUTMENT; LXB
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COCHLEAR BONE ANCHORED SOLUTIONS AB FLANGE FIXTURE AND ABUTMENT; LXB Back to Search Results
Model Number N/A
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Host-Tissue Reaction (1297)
Event Type  Injury  
Manufacturer Narrative
(b)(4).Implanted device remains.
 
Event Description
Per the clinic, the patient experienced a skin overgrowth at the abutment site.Subsequently, the patient was placed under general anesthesia and underwent revision surgery (date not reported) to remove excess skin during an abutment change.The implanted device remains.
 
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Brand Name
FLANGE FIXTURE AND ABUTMENT
Type of Device
LXB
Manufacturer (Section D)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
po box 82
mölnlycke, 435 2 2
SW  435 22
Manufacturer (Section G)
COCHLEAR AMERICAS
13059 east peakview avenue
centennial, co 80111
Manufacturer Contact
kristel kohne
1 university avenue
macqaurie university, nsw 2109
AS   2109
2 9428 655
MDR Report Key6016018
MDR Text Key56913945
Report Number6000034-2016-02006
Device Sequence Number1
Product Code LXB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K955713
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Health Professional
Type of Report Initial
Report Date 09/21/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/10/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberN/A
Device Catalogue Number90434
Device Lot Number607351
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date09/21/2016
Date Manufacturer Received09/21/2016
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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