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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPLANT TL RP 4.1X12MM; DENTAL IMPLANT
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IMPLANT TL RP 4.1X12MM; DENTAL IMPLANT Back to Search Results
Model Number 3631153DU0ACE
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code Inadequate Osseointegration (2646)
Date of Event 02/06/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The investigation of the complaint was carried out considering the analysis of the information given by the dentist in the guarantee form, visual conference of the product returned by the dentist and the evaluation of relevant production records.
 
Event or Problem Description
Missing primary stability.
 
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Brand Name
IMPLANT TL RP 4.1X12MM
Common Device Name
DENTAL IMPLANT
MDR Report Key12681177
Report Number8010516-2021-00069
Device Sequence Number11802591
Product Code DZE
UDI-Device IdentifierE0HM311531
UDI-Public+E0HM311531/$B44151/14D20230531T
Combination Product (Y/N)N
Initial Reporter CountrySW
PMA/510(K) Number
K122807
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 Expiration Date05/31/2023
Device Model Number3631153DU0ACE
Device Catalogue Number31153
Device Lot NumberB44151
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date10/22/2021
Was Device Evaluated by Manufacturer? (Y/N) Yes
Date Device Manufactured06/29/2018
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 Other;
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