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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIA400 IMPLANT 4MM W ABUTMENT 10MM; COCHLEAR BAHA CONNECT SYSTEM
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COCHLEAR BONE ANCHORED SOLUTIONS AB BIA400 IMPLANT 4MM W ABUTMENT 10MM; COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 93331
Medical Device Problem Code Loss of Osseointegration (2408)
Health Effect - Clinical Code No Code Available (3191)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This report is submitted on december 23, 2019.
 
Event or Problem Description
Per the clinic, the patient experienced a loss of osseointegration of the implant.The patient was reimplanted with a new device.
 
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Brand Name
BIA400 IMPLANT 4MM W ABUTMENT 10MM
Common Device Name
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 Key9508895
Report Number6000034-2019-02884
Device Sequence Number13805365
Product Code MAH
UDI-Device Identifier09321502022385
UDI-Public(01)09321502022385(10)COH1117228
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
PMA/510(K) Number
K121317
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Reporter Type Manufacturer
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/02/2019
Report Date (Section F) 12/23/2019
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
Operator of Device Lay User/Patient
Device Model Number93331
Device Catalogue Number93331
Device Lot NumberCOH1117228
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report to Manufacturer12/02/2019
Initial Date Received by Manufacturer 12/02/2019
Initial Report FDA Received Date12/22/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Date Report Sent to FDA12/23/2019
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