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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC SIMPLY LEGACY¿2 IMPLANT; DENTAL IMPLANT
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IMPLANT DIRECT SYBRON MANUFACTURING LLC SIMPLY LEGACY¿2 IMPLANT; DENTAL IMPLANT Back to Search Results
Catalog Number 823211U
Device Problem Device-Device Incompatibility (2919)
Patient Problem Failure of Implant (1924)
Event Date 05/15/2018
Event Type  Injury  
Event Description
Per the complaint, driver would not continue to insert or remove implant.Connection between driver and implant seems to have stripped.The implant was in the osteotomy 1/4 of the way.The implant had to be removed with rongeur.
 
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Brand Name
SIMPLY LEGACY¿2 IMPLANT
Type of Device
DENTAL IMPLANT
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 east hillcrest drive
thousand oaks CA 91362
Manufacturer Contact
adrienne stott
3050 east hillcrest drive
thousand oaks, CA 91362
8184443300
MDR Report Key7617696
MDR Text Key111609935
Report Number3001617766-2018-00154
Device Sequence Number1
Product Code DZE
UDI-Device Identifier10841307107316
UDI-Public10841307107316
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
Remedial Action Replace
Type of Report Initial
Report Date 06/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Dentist
Device Expiration Date11/21/2022
Device Catalogue Number823211U
Device Lot Number104302
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/05/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/21/2017
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 Outcome(s) Required Intervention;
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