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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 92346
Device Problem Loss of Osseointegration (2408)
Patient Problem Inadequate Osseointegration (2646)
Event Type  Injury  
Manufacturer Narrative
This report is submitted on august 09, 2021.
 
Event Description
Per the clinic, the patient experienced a loss of osseointegration resulting in fixture loss. The patient was reimplanted with another cochlear device (specific date not reported).
 
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Brand NameCOCHLEAR BAHA CONNECT SYSTEM
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
Manufacturer (Section G)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
po box 82
mölnlycke 435 2 2
SW 435 22
Manufacturer Contact
belinder gill
unit ug-1, vertical podium
no.8 jalan kerinchi,
kuala lumpur, wilayah persekutuan 59200
MY   59200
MDR Report Key12292408
MDR Text Key265554519
Report Number6000034-2021-02386
Device Sequence Number1
Product Code LXB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K100360
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 07/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number92346
Device Catalogue Number92346
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/19/2021
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 Treatment Data
Date Received: 08/09/2021 Patient Sequence Number: 1
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