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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BA300 ABUTMENT 9MM COCHLEAR BAHA CONNECT SYSTEM

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COCHLEAR BONE ANCHORED SOLUTIONS AB BA300 ABUTMENT 9MM COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 92131
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Bacterial Infection (1735)
Event Date 10/20/2017
Event Type  Injury  
Manufacturer Narrative

This report is submitted on december 22, 2017. Registration number (b)(4).

 
Event Description

Per the clinic, the patient developed an infection at the implant site. Subsequently, the abutment was removed; however, the implanted fixture remains insitu. There are plans to resume use of the device once the site has healed.

 
Manufacturer Narrative

Additional information was received: per the clinic, the abutment removal was conducted under a general anaesthetic on october 20, 2017, where there was a skin revision. The site has reportedly since healed and the patient has resumed use of the device. The reported adverse event is associated with a returned device; however, the provided clinical information was reviewed by the manufacturer and no specific device analysis is deemed necessary at this time. Previous product examinations have not showed any relationship between a product geometrical deviation and the reported clinical complication. Additionally, there are no indications that a product failure has contributed to the reported issue. Adverse skin reactions around the baha abutment, ranging from slight redness to infected tissue, are common complications with baha implants, and can occur at any time following implantation. The report frequency for these complications is being monitored under cbas complaint and medical device reporting data monitoring plan and the status is updated on a monthly basis. This event is added to this monitoring.

 
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Brand NameBA300 ABUTMENT 9MM
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
sujeewa wijesinghe
1 university avenue
macqaurie university, nsw 2109
AS   2109
MDR Report Key7140572
MDR Text Key95583592
Report Number6000034-2017-02285
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
Reporter Country CodeUK
PMA/PMN NumberK100360
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 01/15/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/21/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number92131
Device Catalogue Number92131
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/04/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/15/2018
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: 12/21/2017 Patient Sequence Number: 1
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