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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB FLANGE FIXTURE ST 4MM W. BAHA ABUTMENT; COCHLEAR BAHA CONNECT SYSTEM
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COCHLEAR BONE ANCHORED SOLUTIONS AB FLANGE FIXTURE ST 4MM W. BAHA ABUTMENT; COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 90434
Device Problem Loss of Osseointegration (2408)
Patient Problem Head Injury (1879)
Event Type  Injury  
Manufacturer Narrative
This report is submitted on (b)(6) 2017.(b)(4).
 
Event Description
Per the clinic, the patient experienced a loss of osseointegration resulting in fixture loss, subsequent to sustaining a head trauma.It is unknown if there are plans to re-implant the patient with a new device.
 
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Brand Name
FLANGE FIXTURE ST 4MM W. BAHA ABUTMENT
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 Contact
kristel kohne
1 university avenue
macquarie university, nsw 2109,
AS   2109,
MDR Report Key7150424
MDR Text Key95896921
Report Number6000034-2017-02310
Device Sequence Number1
Product Code LXB
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K955713
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 12/05/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number90434
Device Catalogue Number90434
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/01/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/05/2017
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 N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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