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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB COCHLEAR BAHA CONNECT SYSTEM; LXB
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COCHLEAR BONE ANCHORED SOLUTIONS AB COCHLEAR BAHA CONNECT SYSTEM; LXB Back to Search Results
Model Number BIA300
Device Problem Loss of Osseointegration (2408)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
This report is submitted on (b)(6) 2016 by (b)(4).Device not available for analysis.
 
Event Description
Per the clinic, the patient experienced a loss of osseointegration resulting in fixture loss (date not reported).
 
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Brand Name
COCHLEAR BAHA CONNECT SYSTEM
Type of Device
LXB
Manufacturer (Section D)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
po box 82
mölnlycke 435 33,
SW 
Manufacturer (Section G)
COCHLEAR AMERICAS
13059 east peakview avenue
centennial, co 80111, us
Manufacturer Contact
pavana nayak
1 university avenue
macquarie university, nsw 2109
AS   2109
MDR Report Key6032890
MDR Text Key57552166
Report Number6000034-2016-02066
Device Sequence Number1
Product Code LXB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K100360
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Audiologist
Type of Report Initial
Report Date 09/28/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/17/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberBIA300
Device Catalogue Number92127
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date09/28/2016
Date Manufacturer Received09/28/2016
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;
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