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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; COCHLEAR BAHA CONNECT SYSTEM
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COCHLEAR BONE ANCHORED SOLUTIONS AB FLANGE FIXTURE ST 4MM; COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 90432
Device Problems Failure to Osseointegrate (1863); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Code Available (3191)
Event Date 01/03/2020
Event Type  Injury  
Manufacturer Narrative
This report is submitted on february 25, 2020.
 
Event Description
Per the surgeon, the patient experienced a loss of osseointegration of the implant.A re-implantation is planned (date unknown).
 
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Brand Name
FLANGE FIXTURE ST 4MM
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
roberta loveday
1 university avenue
macquarie university, nsw 2109,
AS   2109,
MDR Report Key9748422
MDR Text Key181773495
Report Number6000034-2020-00501
Device Sequence Number1
Product Code LXB
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K984162
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Initial
Report Date 01/31/2020
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 Number90432
Device Catalogue Number90432
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/31/2020
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/31/2020
Initial Date FDA Received02/24/2020
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;
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