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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 Appropriate Term/Code Not Available (3191)
Patient Problems Host-Tissue Reaction (1297); Bacterial Infection (1735)
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

Per the clinic, the patient experienced a skin overgrowth on the abutment and subsequently underwent revision surgery on (b)(6) 2018. During the procedure, the skin was excised and the patient was administered oral and topical antibiotics. The abutment was removed and replaced with a cover screw to allow time for the abutment site to heal before replacing the abutment. The patient is being clinically managed by the heath care provider.

 
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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 (Section G)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
po box 82
mölnlycke 43533
SW 43533
Manufacturer Contact
tamara martin
1 university avenue
macquarie university, nsw 2109
AS   2109
MDR Report Key8049282
MDR Text Key126498956
Report Number6000034-2018-02195
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberASKU
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 11/02/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/07/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number92132
Device Catalogue Number92132
Device LOT NumberASKU
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/02/2018
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 Initial

Patient TREATMENT DATA
Date Received: 11/07/2018 Patient Sequence Number: 1
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