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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BI300 IMPLANT 4 MM; COCHLEAR BAHA CONNECT SYSTEM

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COCHLEAR BONE ANCHORED SOLUTIONS AB BI300 IMPLANT 4 MM; COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 92129
Device Problem Loss of Osseointegration (2408)
Patient Problems Unspecified Infection (1930); Scar Tissue (2060)
Event Date 03/30/2021
Event Type  Injury  
Event Description
Per the clinic, the patient experienced granulation at the abutment site and was treated with a topical antibiotic (date and duration not reported).On (b)(6) 2021, the patient experienced a loss of osseointegration, resulting in fixture loss.The patient has not yet been reimplanted with a new device as of the date of this report.
 
Event Description
Per the surgeon, patient experienced an infection around the abutment site.
 
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Brand Name
BI300 IMPLANT 4 MM
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 Key11713625
MDR Text Key246993163
Report Number6000034-2021-01099
Device Sequence Number1
Product Code LXB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Type of Report Initial,Followup
Report Date 06/10/2021,05/18/2021
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 Model Number92129
Device Catalogue Number92129
Device Lot NumberASKU
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/10/2021
Distributor Facility Aware Date05/18/2021
Date Report to Manufacturer06/10/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/23/2021
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received06/10/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age58 YR
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