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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 203710
Medical Device Problem Code Loss of Osseointegration (2408)
Health Effect - Clinical Codes Failure of Implant (1924); Pain (1994); Osteopenia/ Osteoporosis (2651)
Date of Event 02/10/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Patient's identifier and weight were not provided.When the requested information becomes available, a supplementary report will be submitted.Pma/510(k) - not applicable.This complaint is being submitted late due to the furloughs that resulted from the global pandemic and is captured within (b)(4).
 
Event or Problem Description
Per complaint (b)(4), patient experienced loss or failure of implant to integrate.
 
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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 Key10859513
Report Number3001617766-2020-08000
Device Sequence Number19741389
Product Code DZE
UDI-Device Identifier10841307105411
UDI-Public10841307105411
Combination Product (Y/N)N
Initial Reporter CountryNL
PMA/510(K) Number
NA
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
Device Explanted Year2020
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) 11/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Operator of Device Health Professional
Device Expiration Date07/22/2018
Device Catalogue Number203710
Device Lot Number43053
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/24/2020
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 08/24/2020
Initial Report FDA Received Date11/18/2020
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 Age72 YR
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