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 BA210 ABUTMENT 5.5MM FOR FLANGE FIXTURE; 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 BA210 ABUTMENT 5.5MM FOR FLANGE FIXTURE; COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 92132
Medical Device Problem Code Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code Host-Tissue Reaction (1297)
Date of Event 07/05/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This report is submitted on (b)(6) 2017, by (b)(4).
 
Event or Problem Description
Per the clinic, the patient experienced skin overgrowth at the abutment site.Subsequently, the patient was placed under general anaesthesia for a surgical procedure on (b)(6) 2017, and excess skin was excised and a longer abutment was placed on the fixture.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BA210 ABUTMENT 5.5MM FOR FLANGE FIXTURE
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 Key7027098
Report Number6000034-2017-02003
Device Sequence Number19086223
Product Code LXB
UDI-Device Identifier09321502018951
UDI-Public(01)09321502018951
Combination Product (Y/N)N
Initial Reporter StatePA
Initial Reporter CountryUS
PMA/510(K) Number
K955713
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Audiologist
Type of Report Initial
Report Date (Section B) 10/24/2017
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 Number92132
Device Catalogue Number92132
Was the Report Sent to FDA? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/24/2017
Initial Report FDA Received Date11/13/2017
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;
Patient Age18 YR
-
-