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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB COCHLEAR BAHA ATTACT SYSTEM LXB

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COCHLEAR BONE ANCHORED SOLUTIONS AB COCHLEAR BAHA ATTACT SYSTEM LXB Back to Search Results
Model Number BIM400
Device Problem Extrusion (2934)
Patient Problems Hematoma (1884); Patient Problem/Medical Problem (2688)
Event Date 06/17/2016
Event Type  Injury  
Manufacturer Narrative

The patient date of birth and date of initial implantation was not reported. (b)(4). Implanted device remains.

 
Event Description

Per the clinic, the patient developed a hematoma at the implant site. Subsequently, the hematoma was drained by the patient's physician (date not reported). Following the procedure, the skinflap broke down, resulting in exposure of the internal magnet. Revision surgery is planned; however, it is unknown whether this has yet to occur as of the date of this report.

 
Manufacturer Narrative

(b)(4). Per the clinic, it was reported that the patient was treated with oral and topical antibiotics (date and duration not reported). This report is filed (b)(6) 2016. Implanted device remains.

 
Manufacturer Narrative

Correction: the brand product name is cochlear baha attact system, not flange fixture and abutment, as previously reported. Correction: the common device name and product code is lxb, not mah as previously reported. Correction: the correct model # is bim400, not ba400 as previously reported. Correction: the correct catalog # is 93550, not 93333 as previously reported. Correction: the correct 510(k)# is k131240, not k121317 as previously reported. (b)(4).

 
Manufacturer Narrative

(b)(4). Per the clinic, the patient underwent revision surgery on (b)(6) 2016, to remove the internal magnet and replace with an abutment. (b)(6).

 
Manufacturer Narrative

Correction: the correct patient identifier is (b)(6) , not (b)(6) as previously reported. It was reported that the patient underwent revision surgery on (b)(6) 2016, to remove the internal magnet and abutment was placed on the fixture.

 
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Brand NameCOCHLEAR BAHA ATTACT SYSTEM
Type of DeviceLXB
Manufacturer (Section D)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
po box 82
mölnlycke 435 33, 435 2 2
SW 435 22
Manufacturer (Section G)
COCHLEAR AMERICAS
13059 east parkview avenue
centennial, co 80111
centennial CO 80111
Manufacturer Contact
pavana nayak
1 university avenue
macquarie university, nsw 2109
AS   2109
2 9428 655
MDR Report Key5867404
MDR Text Key51812950
Report Number6000034-2016-01521
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK131240
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation AUDIOLOGIST
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 08/16/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/10/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberBIM400
Device Catalogue Number93550
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date08/16/2016
Event Location No Information
Date Manufacturer Received08/16/2016
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: 08/10/2016 Patient Sequence Number: 1
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