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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY IMPLANTS MANUFACTURING GMBH TIDESIGN 3.5/4.0 - Ø 5.5,1.5MM; ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS
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DENTSPLY IMPLANTS MANUFACTURING GMBH TIDESIGN 3.5/4.0 - Ø 5.5,1.5MM; ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS Back to Search Results
Catalog Number 24287
Medical Device Problem Code Loss of Osseointegration (2408)
Health Effect - Clinical Codes Failure of Implant (1924); Inflammation (1932)
Date of Event 09/13/2023
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Therefore, because a serious injury resulted, this event is reportable per 21 cfr part 803.The device was not evaluated because the issue is a known inherent risk of the device.We will continue to track and monitor the trend.
 
Event or Problem Description
It was reported that a patient experienced a dental implant loss.
 
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Brand Name
TIDESIGN 3.5/4.0 - Ø 5.5,1.5MM
Common Device Name
ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS
Manufacturer (Section D)
DENTSPLY IMPLANTS MANUFACTURING GMBH
rodenbacher chaussee 4
hanau hessen 63457
GM  63457
Manufacturer (Section G)
DENTSPLY IMPLANTS MANUFACTURING GMBH
rodenbacher chaussee 4
hanau hessen 63457
GM   63457
Manufacturer Contact
hannah seevaratnam
221 west philadelphia st.
york, PA 17401
7178457511
MDR Report Key18668485
Report Number3013111692-2024-04161
Device Sequence Number7127585
Product Code NHA
UDI-Device Identifier07392532067532
UDI-Public07392532067532
Combination Product (Y/N)N
Initial Reporter CountryCH
PMA/510(K) Number
K101005
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2023
Reporter Type Manufacturer
Report Source Foreign,Health Professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 02/08/2024
1 Device was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Catalogue Number24287
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date02/07/2024
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 02/07/2024
Initial Report FDA Received Date02/08/2024
Was Device Evaluated by Manufacturer? (Y/N) No
Usage of Device A
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