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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 205116
Medical Device Problem Codes Failure to Osseointegrate (1863); Osseointegration Problem (3003)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 04/07/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Physical analysis cannot be performed as product was not returned.Customer reported no osseointegration.
 
Event or Problem Description
Bone quality at the time of implant failure type iii.Time of loss in relation to the implantation was before prosthetic restoration.Primary stability and osseointegration was not achieved.
 
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Brand Name
INTERNAL HEX IMPLANT
Common Device Name
DENTAL IMPLANT
MDR Report Key12647871
Report Number1287163-2021-52872
Device Sequence Number11072760
Product Code DZE
UDI-Device Identifier00614950004836
UDI-Public00614950004836
Combination Product (Y/N)N
Initial Reporter CountrySP
PMA/510(K) Number
K102981
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
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) 10/18/2021
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 Number205116
Device Catalogue Number205116
Device Lot Number16040008
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/18/2021
Initial Report FDA Received Date10/18/2021
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
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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