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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB FLANGE FIXTURE AND ABUTMENT; LXB
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COCHLEAR BONE ANCHORED SOLUTIONS AB FLANGE FIXTURE AND ABUTMENT; LXB Back to Search Results
Model Number BIM400
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Inflammation (1932)
Event Date 06/02/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).Implanted device remains.
 
Event Description
Per the clinic, the patient developed a soft tissue pressure damage at the implant site.The patient underwent revision surgery on (b)(6) 2016 to remove the magnet.During the procedure, a cover scew was placed and a partial close was performed.The implanted device remains.
 
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Brand Name
FLANGE FIXTURE AND ABUTMENT
Type of Device
LXB
Manufacturer (Section D)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
po box 82
mölnlycke 435 33,
SW 
Manufacturer Contact
pavana nayak
1 university avenue
macquarie university, nsw 2109
AS   2109
MDR Report Key5801599
MDR Text Key49735303
Report Number6000034-2016-01468
Device Sequence Number1
Product Code LXB
Combination Product (y/n)N
Reporter Country CodeAS
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 07/05/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
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 Number98544
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/05/2016
Initial Date FDA Received07/18/2016
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 Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age72 YR
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