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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GNSIS; GENESIS TAPERED IMPLANT BIOSPARK 6.5X11.5
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GNSIS; GENESIS TAPERED IMPLANT BIOSPARK 6.5X11.5 Back to Search Results
Model Number G21152
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Codes Unspecified Infection (1930); Pain (1994)
Date of Event 04/30/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This report is being submitted as part of (b)(4) which identified late reports as part of a remediation effort.This report was missed during the switch from alternative summary reporting to mandatory medical device reporting.
 
Event or Problem Description
Failed to osseointegrate.
 
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Brand Name
GNSIS
Common Device Name
GENESIS TAPERED IMPLANT BIOSPARK 6.5X11.5
MDR Report Key12694082
Report Number3005990499-2021-10472
Device Sequence Number19173264
Product Code DZE
UDI-Device IdentifierD768G211520
UDI-Public+D768G211520/$$323083141280/
Combination Product (Y/N)N
Initial Reporter StateNJ
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2019
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 10/25/2021
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 Date08/30/2023
Device Model NumberG21152
Device Catalogue NumberG21152
Device Lot Number41280
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/02/2019
Initial Report FDA Received Date10/25/2021
Was Device Evaluated by Manufacturer? (Y/N) No
Date Device Manufactured09/04/2018
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age49 YR
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