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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: PRODUCT CODE
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COCHLEAR BONE ANCHORED SOLUTIONS AB FLANGE FIXTURE AND ABUTMENT; LXB: PRODUCT CODE Back to Search Results
Catalog Number 93331
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Bacterial Infection (1735); Meningitis (2389)
Event Type  Injury  
Event Description
Per the clinic, the patient developed an infection at the abutment site and was prescribed oral antibiotics on (b)(6) 2015.Subsequently the patient was hospitalized for para-meningitis (date and duration not reported); the patient was administered intra-venous antibiotics and the implant was explanted on (b)(6) 2015.The device is not available for analysis.
 
Manufacturer Narrative
(b)(4).The device is not available for analysis.
 
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Brand Name
FLANGE FIXTURE AND ABUTMENT
Type of Device
LXB: PRODUCT CODE
Manufacturer (Section D)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvagen 14
po box 82
moinlycke SE-43 5 22
SW  SE-435 22
Manufacturer Contact
nicole hille
13059 east peakview ave
centennial, CO 80111
3037909010
MDR Report Key4685570
MDR Text Key5669981
Report Number6000034-2015-00540
Device Sequence Number1
Product Code LXB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K955713
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 03/23/2015
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 Other
Device Catalogue Number93331
Device Lot Number152398
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/23/2015
Initial Date FDA Received04/13/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Required Intervention;
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