Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB FIXTURE ST 4MM; COCHLEAR BAHA VISTAFIX SYSTEM
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Patient Problem/Medical Problem (2688)
Event Type  Injury  
Manufacturer Narrative
It was reported that the device was discarded and therefore unavailable for analysis by the manufacturer.This report is submitted on september 18, 2017, (b)(4).
 
Event Description
Per the clinic, the patient experienced a loss of osseointegration resulting in fixture loss.Subsequently, the patient was implanted with a new fixture on (b)(6) 2017.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 (Section G)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
po box 82
mölnlycke 43533
SW   43533
Manufacturer Contact
bianca pries
1 university avenue
macquarie university, nsw 2109
AS   2109
MDR Report Key6871447
MDR Text Key86407723
Report Number6000034-2017-01666
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 Medical Assistant
Type of Report Initial
Report Date 08/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/17/2017
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 Number2716303
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received08/27/2017
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 Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-