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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY2 SMB IMPLANT 5.2DX10L; DENTAL IMPLANT
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IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY2 SMB IMPLANT 5.2DX10L; DENTAL IMPLANT Back to Search Results
Model Number 825210
Device Problem Device-Device Incompatibility (2919)
Patient Problem Failure of Implant (1924)
Event Date 09/27/2017
Event Type  malfunction  
Event Description
Per complaint# (b)(4), complainant reported implant top would not disengage from implant.
 
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Brand Name
LEGACY2 SMB IMPLANT 5.2DX10L
Type of Device
DENTAL IMPLANT
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 e hillcrest drive
thousand oaks CA 91362
Manufacturer (Section G)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 e hillcrest drive
thousand oaks CA 91362
Manufacturer Contact
crystal barczi
3050 e hillcrest drive
thousand oaks, CA 91362
8184443300
MDR Report Key7287831
MDR Text Key100781617
Report Number3001617766-2018-00023
Device Sequence Number1
Product Code DZE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K090234
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Dentist
Type of Report Initial
Report Date 02/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Dentist
Device Expiration Date01/27/2021
Device Model Number825210
Device Catalogue Number825210
Device Lot Number94237
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/05/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/01/2017
Initial Date FDA Received02/21/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/29/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age34 YR
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