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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTERNAL HEX IMPLANT; DENTAL IMPLANT
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INTERNAL HEX IMPLANT; DENTAL IMPLANT Back to Search Results
Model Number 205113
Medical Device Problem Codes Failure to Osseointegrate (1863); Osseointegration Problem (3003)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 09/14/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
No evidence was found with the implant itself after evaluation.Customer reported mobility.
 
Event or Problem Description
Mobility was reported.Bone quality at the time of implant failure type ii.Time of loss in relation to the implantation was before prosthetic restoration.Primary stability and osseointegration was not achieved.Augmentation procedure was not performed at the time of surgery.
 
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Brand Name
INTERNAL HEX IMPLANT
Common Device Name
DENTAL IMPLANT
MDR Report Key12684399
Report Number1287163-2021-00949
Device Sequence Number11802601
Product Code DZE
UDI-Device Identifier00614950004829
UDI-Public00614950004829
Combination Product (Y/N)N
Initial Reporter StateMD
Initial Reporter CountryUS
PMA/510(K) Number
K102981
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 10/22/2021
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 Model Number205113
Device Catalogue Number205113
Device Lot Number19020120
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/11/2021
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/11/2021
Initial Report FDA Received Date10/22/2021
Was Device Evaluated by Manufacturer? (Y/N) Yes
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 Age48 YR
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