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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTIUM USA IMPLANTIUM; IMPLANT, ENDOSSEOUS, ROOT-FORM
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DENTIUM USA IMPLANTIUM; IMPLANT, ENDOSSEOUS, ROOT-FORM Back to Search Results
Model Number FX4314MLC
Medical Device Problem Code Use of Device Problem (1670)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 07/19/2017
Type of Reportable Event Serious Injury
Event or Problem Description
The dental implant fx4314mlc was removed on (b)(6) 2017 due to thread damage on the implant on the same day of implantation.The patient has medical history of hypertension and has been recovered without complications.
 
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Brand Name
IMPLANTIUM
Common Device Name
IMPLANT, ENDOSSEOUS, ROOT-FORM
Manufacturer (Section D)
DENTIUM USA
6761 katella ave
cypress CA 90630
MDR Report Key6794322
Report Number3005503242-2017-00045
Device Sequence Number19266489
Product Code DZE
UDI-Device IdentifierD755FX4314MLC0
UDI-PublicD755FX4314MLC0
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K041368
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2017
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 08/15/2017
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 Dentist
Device Expiration Date10/31/2022
Device Model NumberFX4314MLC
Device Catalogue NumberFX4314MLC
Device Lot NumberI18TA632S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/03/2017
Was the Report Sent to FDA? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 08/03/2017
Initial Report FDA Received Date08/15/2017
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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