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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY3 IMPLANT 3.7MMD X 10MML SBMPRODUCT CODE 853710; DENTAL IMPLANT
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IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY3 IMPLANT 3.7MMD X 10MML SBMPRODUCT CODE 853710; DENTAL IMPLANT Back to Search Results
Model Number 853710
Medical Device Problem Code Device Issue (2379)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 04/24/2017
Type of Reportable Event Serious Injury
Event or Problem Description
Customer reported that the implant entered the mandibular canal causing numbness of the lip and chin of the patient.
 
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Brand Name
LEGACY3 IMPLANT 3.7MMD X 10MML SBMPRODUCT CODE 853710
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 e. hillcrest dr.
thousand oaks CA 91362
MDR Report Key7281183
Report Number3001617766-2018-00009
Device Sequence Number11072069
Product Code DZE
UDI-Device Identifier10841307102458
UDI-Public10841307102458
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K090234
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2017
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 02/13/2018
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 Dentist
Device Expiration Date01/25/2022
Device Model Number853710
Device Catalogue Number853710
Device Lot Number88398
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/30/2018
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/19/2018
Initial Report FDA Received Date02/19/2018
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 Age78 YR
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