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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 303513
Medical Device Problem Codes Failure to Osseointegrate (1863); Osseointegration Problem (3003)
Health Effect - Clinical Codes Failure of Implant (1924); Pain (1994)
Date of Event 07/19/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Physical analysis cannot be performed as product was not returned.Customer reported pain, mobility, bleeding, and swelling.
 
Event or Problem Description
Pain, mobility, bleeding and swelling were reported.Bone quality at the time of implant failure type iii.Time of loss in relation to the implantation was before prosthetic restoration.Primary stability was achieved.Osseointegration was not achieved.Augmentation procedure was performed at the time of surgery.Patient had radiation (head/neck area) and chemotherapy at the time of implant.Patient has poor oral hygiene.
 
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Brand Name
INTERNAL HEX IMPLANT
Common Device Name
DENTAL IMPLANT
MDR Report Key12657210
Report Number1287163-2021-52879
Device Sequence Number4489917
Product Code DZE
UDI-Device Identifier00614950005192
UDI-Public00614950005192
Combination Product (Y/N)N
Initial Reporter CountryPO
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) 10/19/2021
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 Number303513
Device Catalogue Number303513
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/05/2021
Initial Report FDA Received Date10/19/2021
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 Age58 YR
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