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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BA210 ABUTMENT 8.5MM FOR FLANGE FIXTURE; COCHLEAR BAHA CONNECT SYSTEM
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COCHLEAR BONE ANCHORED SOLUTIONS AB BA210 ABUTMENT 8.5MM FOR FLANGE FIXTURE; COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 92133
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Foreign Body Reaction (1868)
Event Date 08/29/2019
Event Type  Injury  
Manufacturer Narrative
This report is submitted on december 16, 2019.
 
Event Description
Per the clinic, the patient underwent revision surgery on (b)(6) 2019, due to skin overgrowth at the implant site.During the procedure, tissue at the implant site was debrided and granulomanus tissue was excised.The abutment was subsequently removed and the site was cauterised.
 
Manufacturer Narrative
It was reported the patient underwent revision surgery on (b)(6) 2020 in order to have a magnet placed on the internal fixture, converting the patient to a subcutaneous baha implant system.This report is submitted on 19 february 2020.
 
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Brand Name
BA210 ABUTMENT 8.5MM FOR FLANGE FIXTURE
Type of Device
COCHLEAR BAHA CONNECT SYSTEM
Manufacturer (Section D)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
po box 82
mölnlycke, 435 2 2
SW  435 22
MDR Report Key9471002
MDR Text Key170852060
Report Number6000034-2019-02953
Device Sequence Number1
Product Code LXB
Combination Product (y/n)N
PMA/PMN Number
K955713
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 01/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number92133
Device Catalogue Number92133
Device Lot NumberASKU
Was Device Available for Evaluation? No
Date Manufacturer Received01/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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