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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BA210 ABUTMENT 8.5MM FOR FLANGE FIXTURE; COCHLEAR BAHA CONNECT SYSTEM
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COCHLEAR BONE ANCHORED SOLUTIONS AB BA210 ABUTMENT 8.5MM FOR FLANGE FIXTURE; COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 92133
Medical Device Problem Code Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code Patient Problem/Medical Problem (2688)
Date of Event 10/08/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This report is submitted on november 8, 2017, (b)(4).
 
Event or Problem Description
Per the clinic, the patient experienced a loss of abutment on (b)(6) 2017, and was subsequently taken to the or to place a new abutment.During the procedure, granulated tissue was noted over the implant, and was subsequently excised.
 
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Brand Name
BA210 ABUTMENT 8.5MM 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 Key7007915
Report Number6000034-2017-01977
Device Sequence Number16544457
Product Code LXB
UDI-Device Identifier09321502018968
UDI-Public(01)09321502018968
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) 10/18/2017
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 Number92133
Device Catalogue Number92133
Was the Report Sent to FDA? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/18/2017
Initial Report FDA Received Date11/07/2017
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
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