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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 Appropriate Term/Code Not Available (3191)
Patient Problem Bone Fracture(s) (1870)
Event Date 06/15/2015
Event Type  Injury  
Event Description
Per the clinic, the patient experienced a head injury at the implant site resulting in loosening of the implanted device.The device was explanted on (b)(6) 2015.It is unknown if there are plans to reimplant the patient with a new device as of the date of this report, (b)(6) 2015.
 
Manufacturer Narrative
(b)(4).Device not yet 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 2 2
SW  435 22
Manufacturer Contact
rebekka jeger
1 university avenue
macquarie university, nsw 2109
AS   2109
1294286300
MDR Report Key4911197
MDR Text Key6026026
Report Number6000034-2015-01313
Device Sequence Number1
Product Code LXB
Combination Product (y/n)N
Reporter Country CodeEZ
PMA/PMN Number
K121317
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 06/17/2015
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/17/2015
Initial Date FDA Received07/14/2015
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 Age18 YR
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