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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTERNAL HEX (PS); DENTAL IMPLANT
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INTERNAL HEX (PS); DENTAL IMPLANT Back to Search Results
Model Number 214711
Medical Device Problem Code Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 09/21/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
No evidence was found with the implant itself after evaluation.Customer reported mobility and peri-implantitis.
 
Event or Problem Description
Peri-implantitis and mobility were 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 achieved.Augmentation procedure (allograft) was performed at the time of surgery.
 
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Brand Name
INTERNAL HEX (PS)
Common Device Name
DENTAL IMPLANT
MDR Report Key12677185
Report Number1287163-2021-00948
Device Sequence Number1507496
Product Code DZE
UDI-Device Identifier00614950007196
UDI-Public00614950007196
Combination Product (Y/N)N
Initial Reporter StateMD
Initial Reporter CountryUS
PMA/510(K) Number
K103790
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) 10/21/2021
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 Number214711
Device Catalogue Number214711
Device Lot Number21010098
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 Date10/21/2021
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 Age43 YR
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