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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 Failure to Osseointegrate (1863)
Health Effect - Clinical Codes Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Osteopenia/ Osteoporosis (2651)
Date of Event 05/13/2019
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), patient experienced inflammation, bone loss,infection and swelling.Implant failed 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 Key8987217
Report Number3001617766-2019-02662
Device Sequence Number19664189
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 Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source distributor,foreign,health pr
Initial Reporter Occupation Non-Healthcare Professional
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 Catalogue Number203711
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/11/2019
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 Age58 YR
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