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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 Problem Loss of Osseointegration (2408)
Patient Problem Unspecified Infection (1930)
Event Type  Injury  
Manufacturer Narrative

This report is submitted on march 23, 2021.

 
Event Description

Per the clinic, the patient experienced a loss of osseointegration resulting in fixture loss. An infection was also present, with the patient being treated with oral and topical antibiotics (date and duration not reported).

 
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Brand NameFLANGE FIXTURE ST 4MM
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 Key11548292
MDR Text Key241708930
Report Number6000034-2021-00851
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
Reporter Country CodeCO
PMA/PMN NumberK984162
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 02/27/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/22/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/01/2015
Device MODEL Number90432
Device Catalogue Number90432
Device LOT NumberCOH173884
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/27/2021
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: 03/22/2021 Patient Sequence Number: 1
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