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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB; COCHLEAR BAHA CONNECT SYSTEM

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COCHLEAR BONE ANCHORED SOLUTIONS AB; COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number ASKU
Device Problem Loss of Osseointegration (2408)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
This report is filed on october 03, 2019.
 
Event Description
Per the clinic, the patient experienced a loss of osseointegration, resulting in fixture loss.Re-implantation is planned but has not taken place as of the date of this report.
 
Event Description
Correction: the previous or initial mdr submitted on (b)(6) 2019 was filed inadvertently.The reported device is not manufactured by cochlear, therefore no serious injury has occurred.
 
Manufacturer Narrative
This report is submitted on 11 november 2019.
 
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Brand Name
NI
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
MDR Report Key9149337
MDR Text Key161072626
Report Number6000034-2019-02040
Device Sequence Number1
Product Code LXB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Type of Report Initial,Followup
Report Date 11/11/2019,10/16/2019
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 NumberASKU
Device Catalogue NumberASKU
Device Lot NumberASKU
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/11/2019
Distributor Facility Aware Date10/16/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/02/2019
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received11/10/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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