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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: PRODUCT CODE
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COCHLEAR BONE ANCHORED SOLUTIONS AB FLANGE FIXTURE AND ABUTMENT; LXB: PRODUCT CODE Back to Search Results
Catalog Number 90434
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Abscess (1690); Reaction (2414)
Event Date 10/21/2014
Event Type  Injury  
Event Description
Per the clinic, the patient developed an abscess at the implant site, she was administered general anesthesia on (b)(6) 2014 and the site was drained.Subsequently the patient underwent a second procedure on (b)(6) 2015 to have excess skin excised and a longer abutment placed due to continued soft tissue reaction at the implant site.The implanted device remains.
 
Manufacturer Narrative
(b)(4).The implanted device remains.
 
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Brand Name
FLANGE FIXTURE AND ABUTMENT
Type of Device
LXB: PRODUCT CODE
Manufacturer (Section D)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvagen 14
po box 82
moinlycke SE-43 5 22
SW  SE-435 22
Manufacturer Contact
nicole hille
13059 east peakview ave
centennial, CO 80111
3037909010
MDR Report Key4788953
MDR Text Key5804404
Report Number6000034-2015-00783
Device Sequence Number1
Product Code LXB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K984162
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Audiologist
Type of Report Initial
Report Date 04/30/2015
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 Other
Device Catalogue Number90434
Device Lot NumberCOH118934
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/30/2015
Initial Date FDA Received05/21/2015
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 Age24 YR
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