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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Type  Injury  
Manufacturer Narrative
The implanted device remains.
 
Event Description
Per the clinic, the patient experienced infection at the abutment site.Subsequently, the patient underwent revision surgery to excise the excess skin (date not reported) and was prescribed oral antibiotics (date not reported).On (b)(6) 2015, the patient underwent another revision surgery; the excess skin was excised and the abutment was removed.The patient was also prescribed oral antibiotics.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, se 435-2 2
SW  435-22
Manufacturer Contact
angel wright
13059 east peakview avenue
centennial, CO 80111
3037909010
MDR Report Key5333011
MDR Text Key34644595
Report Number6000034-2015-02592
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 Physician
Type of Report Initial
Report Date 12/04/2015
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 Lay User/Patient
Device Model NumberN/A
Device Catalogue Number93331
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/04/2015
Initial Date FDA Received12/29/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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