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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BAHA FLANGE & ABUTMENT; LXB: PRODUCT CODE

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COCHLEAR BONE ANCHORED SOLUTIONS AB BAHA FLANGE & ABUTMENT; LXB: PRODUCT CODE Back to Search Results
Catalog Number 93329
Device Problem Loss of Osseointegration (2408)
Patient Problem Hearing Impairment (1881)
Event Type  Injury  
Manufacturer Narrative
This report is filed, march 10, 2016.The device is currently unavailable.
 
Event Description
Per the clinic, the patient experienced a loss of osseointegration (date not reported) resulting in fixture loss.The patient was reimplanted with another device on (b)(6) 2016.
 
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Brand Name
BAHA FLANGE & 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 Key5493651
MDR Text Key40113227
Report Number6000034-2016-00547
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 Other
Type of Report Initial
Report Date 02/19/2016
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 Catalogue Number93329
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/19/2016
Initial Date FDA Received03/10/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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