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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIM400 IMPLANT MAGNET COCHLEAR BAHA ATTRACT SYSTEM

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COCHLEAR BONE ANCHORED SOLUTIONS AB BIM400 IMPLANT MAGNET COCHLEAR BAHA ATTRACT SYSTEM Back to Search Results
Model Number 93550
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem No Code Available (3191)
Event Date 10/06/2016
Event Type  Malfunction  
Manufacturer Narrative

This report is submitted on (b)(6), 2016, by (b)(4). Magnet not received by manufacturer.

 
Event Description

Per the clinic, during implantation surgery on (b)(6) 2016, the surgeon removed the magnet from its packaging and it was discovered that the internal screw was missing. The implant was placed; however, a subsequent revision surgery will be required in order to place the internal magnet.

 
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Brand NameBIM400 IMPLANT MAGNET
Type of DeviceCOCHLEAR BAHA ATTRACT 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 AMERICAS
13059 east parkview avenue
centennial CO 80111
Manufacturer Contact
bianca hanlon
1 university avenue
macqaurie university, nsw 2109
AS   2109
2 9428 655
MDR Report Key6065995
MDR Text Key58721800
Report Number6000034-2016-02100
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 HEALTH PROFESSIONAL
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 10/06/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/30/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number93550
Device Catalogue Number93550
Device LOT Number109437
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/06/2016
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: 10/30/2016 Patient Sequence Number: 1
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