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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC SCREWPLANT IMPLANT; DENTAL IMPLANT
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IMPLANT DIRECT SYBRON MANUFACTURING LLC SCREWPLANT IMPLANT; DENTAL IMPLANT Back to Search Results
Catalog Number 103710
Medical Device Problem Code Positioning Problem (3009)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 07/25/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Patient identifier, age, weight and other relevant history, including preexisting medical conditions were not provided.When the requested information becomes available, a supplementary report will be submitted.Lot information unknown.If additional information becomes available a supplementary report will be submitted.Device evaluation results are not available.When the analysis is complete, a supplemental report will be submitted.This complaint is being submitted late due to the furloughs that resulted from the global pandemic and is captured within deviation 1412.
 
Event or Problem Description
Per complaint (b)(4), before clinical procedure, patient experienced lack of primary stability.
 
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Brand Name
SCREWPLANT IMPLANT
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 east hillcrest drive
thousand oaks CA 91362
MDR Report Key11848504
Report Number3001617766-2021-02728
Device Sequence Number16949750
Product Code DZE
UDI-Device Identifier10841307104919
UDI-Public10841307104919
Combination Product (Y/N)N
Initial Reporter CountryEG
PMA/510(K) Number
K061319
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source distributor,foreign,health pr
Initial Reporter Occupation Dentist
Remedial Action Inspection
Type of Report Initial
Report Date (Section B) 05/19/2021
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 Catalogue Number103710
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 12/23/2020
Initial Report FDA Received Date05/19/2021
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;
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