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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC SCREWPLUS IMPLANT; DENTAL IMPLANT
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IMPLANT DIRECT SYBRON MANUFACTURING LLC SCREWPLUS IMPLANT; DENTAL IMPLANT Back to Search Results
Catalog Number 203711
Medical Device Problem Code Break (1069)
Health Effect - Clinical Codes Failure of Implant (1924); Osteopenia/ Osteoporosis (2651)
Date of Event 10/04/2017
Type of Reportable Event Serious Injury
Event or Problem Description
Per complaint (b)(4), the locator broken down and the prosthesis no longer clicks.This resulted in the implant being removed, bone by place and re-implanted.
 
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Brand Name
SCREWPLUS IMPLANT
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 east hillcrest drive
thousand oaks CA 91362
MDR Report Key7900249
Report Number3001617766-2018-00234
Device Sequence Number1395050
Product Code DZE
UDI-Device Identifier10841307105428
UDI-Public10841307105428
Combination Product (Y/N)N
Initial Reporter CountryNL
PMA/510(K) Number
K061319
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2010
Device Explanted Year2017
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Non-Healthcare Professional
Remedial Action Inspection
Type of Report Initial
Report Date (Section B) 09/21/2018
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 Date04/10/2014
Device Catalogue Number203711
Device Lot Number21453
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/31/2018
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 08/22/2018
Initial Report FDA Received Date09/21/2018
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 Age71 YR
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