• 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 FLANGE FIXTURE ST 4MM 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 FLANGE FIXTURE ST 4MM COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 90432
Device Problem Loss of Osseointegration (2408)
Patient Problem Head Injury (1879)
Event Type  Injury  
Manufacturer Narrative

This report is submitted on july 21 2020.

 
Event Description

Per the clinic, the patient experienced a loss of osseointegration subsequent to sustaining a head trauma. The patient was reimplanted with another cochlear device on (b)(6) 2020.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameFLANGE FIXTURE ST 4MM
Type of DeviceCOCHLEAR BAHA CONNECT SYSTEM
Manufacturer (Section D)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
po box 82
mölnlycke, 435 2 2
SW 435 22
Manufacturer (Section G)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
po box 82
mölnlycke, 435 2 2
SW 435 22
Manufacturer Contact
kohilah nadaraja
unit ug-1, vertical podium
no. 8 jalan kerinchi,
kuala lumpur, wilayah persekutuan 59200
MY   59200
MDR Report Key10300011
MDR Text Key199652819
Report Number6000034-2020-01892
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberK955713
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 07/06/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/20/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/01/2009
Device MODEL Number90432
Device Catalogue Number90432
Device LOT Number601550
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/06/2020
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: 07/20/2020 Patient Sequence Number: 1
-
-