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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TRICAM INTERNAL IMPLANT; DENTAL IMPLANT
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TRICAM INTERNAL IMPLANT; DENTAL IMPLANT Back to Search Results
Model Number 303513
Medical Device Problem Code Osseointegration Problem (3003)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 07/12/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
No evidence was found with the implant itself after evaluation.Customer reported no osseointegration and mobility.
 
Event or Problem Description
Mobility was reported.Bone quality at the time of implant failure type i.Time of loss in relation to the implantation was up to 1 year after prosthetic restoration.Primary stability and osseointegration was not achieved.Augmentation procedure was not performed at the time of surgery.Patient has diabetes.
 
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Brand Name
TRICAM INTERNAL IMPLANT
Common Device Name
DENTAL IMPLANT
MDR Report Key12615060
Report Number1287163-2021-00944
Device Sequence Number11100292
Product Code DZE
UDI-Device Identifier00614950005192
UDI-Public00614950005192
Combination Product (Y/N)N
Initial Reporter StateSC
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) 10/12/2021
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 Number20020029
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/23/2021
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/23/2021
Initial Report FDA Received Date10/12/2021
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 Age71 YR
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