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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
Catalog Number 93330
Device Problem Insufficient Information (3190)
Patient Problem Death (1802)
Event Date 07/23/2014
Event Type  Death  
Event Description
Per the clinic, the patient expired on (b)(6) 2014, subsequent to undergoing initial implant surgery on (b)(6) 2014.No complication were reported during the implant surgery.Additional information has been requested but has not been made available as of the date of this report, (b)(6) 2014.
 
Manufacturer Narrative
(b)(4).Device not received by manufacturer.
 
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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 22
SW  435 22
Manufacturer Contact
rebekka jeger
1 university avenue
macquarie university, nsw 2109
AS   2109
1294286300
MDR Report Key4022353
MDR Text Key4727900
Report Number6000034-2014-01116
Device Sequence Number1
Product Code LXB
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K121317
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Health Professional
Type of Report Initial
Report Date 07/24/2014
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 Catalogue Number93330
Device Lot Number134811
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/24/2014
Initial Date FDA Received08/20/2014
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) Death;
Patient Age70 YR
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