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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY 1 IMPLANT; DENTAL IMPLANT
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IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY 1 IMPLANT; DENTAL IMPLANT Back to Search Results
Catalog Number 803716
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Codes Failure of Implant (1924); No Consequences Or Impact To Patient (2199)
Date of Event 09/19/2018
Type of Reportable Event Serious Injury
Event or Problem Description
Per complaint (b)(4), a patient experienced a dental implant fracture.The failed implant was removed for later implantation.No patient impact was reported.
 
Additional Manufacturer Narrative
Provided device evaluation information and updated evaluation codes to reflect result.
 
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Brand Name
LEGACY 1 IMPLANT
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 east hillcrest drive
thousand oaks CA 91362
MDR Report Key8010076
Report Number3001617766-2018-00283
Device Sequence Number18874308
Product Code DZE
UDI-Device Identifier10841307100829
UDI-Public10841307100829
Combination Product (Y/N)N
Initial Reporter CountryCA
PMA/510(K) Number
K061319
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Device Explanted Year2018
Reporter Type Manufacturer
Report Source foreign,health professional,u
Initial Reporter Occupation Dentist
Remedial Action Inspection
Type of Report Initial,Followup
Report Date (Section B) 12/18/2018
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 Health Professional
Device Expiration Date05/17/2020
Device Catalogue Number803716
Device Lot Number62875
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/30/2018
Initial Date Received by Manufacturer 09/26/2018
Supplement Date Received by Manufacturer12/07/2018
Initial Report FDA Received Date10/26/2018
Supplement Report FDA Received Date12/18/2018
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 Age84 YR
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