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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BA210 ABUTMENT 5.5MM FOR FLANGE FIXTURE COCHLEAR BAHA CONNECT SYSTEM

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COCHLEAR BONE ANCHORED SOLUTIONS AB BA210 ABUTMENT 5.5MM FOR FLANGE FIXTURE COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 92132
Device Problem Loss of Osseointegration (2408)
Patient Problem Head Injury (1879)
Event Date 07/01/2020
Event Type  Injury  
Manufacturer Narrative
This report is submitted on december 15, 2020.
 
Event Description
Per the clinic, the patient experienced a loss of fixture in (b)(6) 2020 (specific date not reported) subsequent to sustaining a head trauma. It is unknown if there are plans to reimplant the patient as of the date of this report.
 
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Brand NameBA210 ABUTMENT 5.5MM FOR FLANGE FIXTURE
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 Contact
weiting zhen
1 university avenue
macquarie university, nsw 2109
AS   2109
MDR Report Key11009549
MDR Text Key221497050
Report Number6000034-2020-03452
Device Sequence Number1
Product Code LXB
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K955713
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 11/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number92132
Device Catalogue Number92132
Device Lot NumberCOH139318
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/26/2020
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 Treatment Data
Date Received: 12/15/2020 Patient Sequence Number: 1
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