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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 Discharge (2225)
Event Date 01/29/2016
Event Type  Injury  
Manufacturer Narrative
This report is filed, february 18, 2016.The implanted device remains.
 
Event Description
Per the clinic, the patient experienced discharge from the abutment site and was treated with a topical ointment.Subsequently on (b)(6) 2016 the patient's abutment fell off.The implant device remains.
 
Manufacturer Narrative
Per the clinic, the patient was prescribed a 10 course of oral antibiotics (date not reported).The implanted device remains.This report is filed july 6, 2016.
 
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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, se 435-2 2
SW  435-22
Manufacturer Contact
angel wright
13059 east peakview avenue
centennial, CO 80111
3037909010
MDR Report Key5444334
MDR Text Key38455454
Report Number6000034-2016-00423
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 company representative
Reporter Occupation Audiologist
Type of Report Initial,Followup
Report Date 02/22/2016
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 No Information
Device Model NumberN/A
Device Catalogue Number93333
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/29/2016
Initial Date FDA Received02/18/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received07/07/2016
Was Device Evaluated by Manufacturer? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age67 YR
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