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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB FIXTURE ST 4MM; COCHLEAR BAHA VISTAFIX SYSTEM
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COCHLEAR BONE ANCHORED SOLUTIONS AB FIXTURE ST 4MM; COCHLEAR BAHA VISTAFIX SYSTEM Back to Search Results
Model Number 90440
Device Problem Loss of Osseointegration (2408)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
Per the clinic, the patient experienced a loss of osseointegration, resulting in fixture loss (date not reported).Re-implantation is planned but has not taken place as of the date of this report.
 
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Brand Name
FIXTURE ST 4MM
Type of Device
COCHLEAR BAHA VISTAFIX 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 Key6790941
MDR Text Key82556209
Report Number6000034-2017-01565
Device Sequence Number1
Product Code FZE
UDI-Device Identifier09321502014328
UDI-Public(01)09321502014328
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K945154
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Health Professional
Type of Report Initial
Report Date 08/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/14/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number90440
Device Catalogue Number90440
Device Lot Number2071603
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received08/08/2017
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 N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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