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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 Inadequate Osseointegration (2646)
Event Type  Injury  
Manufacturer Narrative
This report is submitted on october 13, 2020.
 
Event Description
Per the surgeon, the patient experienced a loss of osseointegration of the implant. The patient has been re-implanted with another device.
 
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Brand NameFLANGE FIXTURE ST 4MM W. BAHA ABUTMENT
Type of DeviceCOCHLEAR BAHA CONNECT SYSTEM
Manufacturer (Section D)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
po box 82
mölnlycke, 435 2 2
SW 435 22
MDR Report Key10668189
MDR Text Key211250573
Report Number6000034-2020-02853
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
Reporter Occupation
Type of Report Initial
Report Date 09/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number90434
Device Catalogue Number90434
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/24/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/24/2020
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

Patient Treatment Data
Date Received: 10/12/2020 Patient Sequence Number: 1
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