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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
Model Number 203710
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Codes Failure of Implant (1924); Impaired Healing (2378)
Date of Event 06/24/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Lot information and other relevant history are unknown and if it becomes available a follow-up report will be submitted.
 
Event or Problem Description
(b)(4), patient experienced loss 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
MDR Report Key9851689
Report Number3001617766-2020-02167
Device Sequence Number16862523
Product Code DZE
UDI-Device Identifier10841307105411
UDI-Public10841307105411
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) 03/19/2020
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 Date02/25/2020
Device Model Number203710
Device Catalogue Number203710
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/25/2020
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 02/24/2020
Initial Report FDA Received Date03/19/2020
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;
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