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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BI300 IMPLANT 3MM COCHLEAR BAHA CONNECT SYSTEM

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COCHLEAR BONE ANCHORED SOLUTIONS AB BI300 IMPLANT 3MM COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 92128
Device Problems Loss of Osseointegration (2408); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Inadequate Osseointegration (2646); No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Injury  
Manufacturer Narrative
This report is submitted on august 02, 2021.
 
Event Description
Per the clinic, the patient experienced a loss of osseointegration resulting in fixture loss. Subsequently, the patient was placed under general anesthesia in order to explant the fixture and implant magnet (date not reported). It is unknown if there are plans to reimplant the patient as of the date of this report.
 
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Brand NameBI300 IMPLANT 3MM
Type of DeviceCOCHLEAR BAHA CONNECT SYSTEM
Manufacturer (Section D)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
po box 82
mölnlycke, 435 3 3
SW 435 33
Manufacturer (Section G)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
po box 82
mölnlycke, 435 3 3
SW 435 33
Manufacturer Contact
durga velayutham
unit ug-1, vertical podium
no.8 jalan kerinchi,
kuala lumpur, wilayah persekutuan 59200
MY   59200
MDR Report Key12257720
MDR Text Key264462881
Report Number6000034-2021-02279
Device Sequence Number1
Product Code LXB
UDI-Device Identifier09321502019538
UDI-Public(01)09321502019538(10)COH1129963(17)220701
Combination Product (y/n)N
Reporter Country CodeAR
PMA/PMN Number
K100360
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/01/2022
Device Model Number92128
Device Catalogue Number92128
Device Lot NumberCOH1129963
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received11/05/2021
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 Treatment Data
Date Received: 08/02/2021 Patient Sequence Number: 1
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