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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 204708
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Codes Failure of Implant (1924); Inflammation (1932)
Date of Event 02/19/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Exemption # e2012017, report late due to asr to individual reporting transition.
 
Event or Problem Description
Per complaint (b)(4), the patient experienced failure or loss of implant to integrate.The implant became loose weeks after placement.
 
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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 Key8987276
Report Number3001617766-2019-02694
Device Sequence Number19469717
Product Code DZE
UDI-Device Identifier10841307105459
UDI-Public10841307105459
Combination Product (Y/N)N
Initial Reporter CountryNL
PMA/510(K) Number
K061319
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source distributor,foreign,health pr
Initial Reporter Occupation Dentist
Remedial Action Inspection
Type of Report Initial
Report Date (Section B) 09/10/2019
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 Date04/27/2022
Device Catalogue Number204708
Device Lot Number93893
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/12/2019
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/21/2019
Initial Report FDA Received Date09/11/2019
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 Age55 YR
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