Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BI300 IMPLANT 3MM; COCHLEAR BAHA CONNECT SYSTEM
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

COCHLEAR BONE ANCHORED SOLUTIONS AB BI300 IMPLANT 3MM; COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 92128
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 04/24/2020
Event Type  Injury  
Manufacturer Narrative
This report is submitted on may 15, 2020.
 
Event Description
Per the clinic, the abutment was removed under a general anesthetic on (b)(6) 2020 due to lack of benefit.A topical antibiotic was applied.The implant remains in-situ.
 
Manufacturer Narrative
Per the clinic it was reported that the patient underwent revision surgery (date not reported) in order to convert the patient to a transcutaneous osia baha implant system.During the procedure, the abutment was removed and an implant was placed on the internal fixture.This report is submitted on 2 september 2020.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BI300 IMPLANT 3MM
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 Key10068441
MDR Text Key191377106
Report Number6000034-2020-01279
Device Sequence Number1
Product Code LXB
Combination Product (y/n)N
PMA/PMN Number
K100360
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial,Followup
Report Date 05/19/2020,08/07/2020
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 Number92128
Device Catalogue Number92128
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/19/2020
Date Report to Manufacturer04/27/2020
Initial Date Manufacturer Received 04/27/2020
Initial Date FDA Received05/19/2020
Supplement Dates Manufacturer Received08/07/2020
Supplement Dates FDA Received09/01/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age55 YR
-
-