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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB UNKNOWN; COCHLEAR BAHA CONNECT SYSTEM
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COCHLEAR BONE ANCHORED SOLUTIONS AB UNKNOWN; COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number UNKNOWN
Device Problem Loss of Osseointegration (2408)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Device details unavailable at the time of this report, this report is filed on november 02, 2016.(b)(4).Device not returned to manufacturer.
 
Event Description
Per the clinic, the patient experienced a loss of osseointegration (date not reported) resulting in fixture loss.Re-implantation is planned but has not occurred as of the date of this report november 02, 2016.
 
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Brand Name
UNKNOWN
Type of Device
COCHLEAR BAHA CONNECT SYSTEM
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 Key6071725
MDR Text Key58922792
Report Number6000034-2016-02210
Device Sequence Number1
Product Code LXB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Audiologist
Type of Report Initial
Report Date 10/21/2016
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 Lay User/Patient
Device Model NumberUNKNOWN
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date10/21/2016
Initial Date Manufacturer Received 10/21/2016
Initial Date FDA Received11/02/2016
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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