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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY IMPLANTS MANUFACTURING GMBH OSSEOSPEED TX 4.5 - 9 MM; IMPLANT, ENDOSSEOUS, ROOT-FORM
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DENTSPLY IMPLANTS MANUFACTURING GMBH OSSEOSPEED TX 4.5 - 9 MM; IMPLANT, ENDOSSEOUS, ROOT-FORM Back to Search Results
Catalog Number 24951
Medical Device Problem Code Loss of Osseointegration (2408)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 01/20/2025
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
OSSEOSPEED TX 4.5 - 9 MM
Common Device Name
IMPLANT, ENDOSSEOUS, ROOT-FORM
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
dan eagar
221 west philadelphia st.
york, PA 17401
MDR Report Key21605141
Report Number3013111692-2025-06616
Device Sequence Number15677467
Product Code DZE
UDI-Device Identifier04048551265499
UDI-Public04048551265499
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K053384
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Device Explanted Year2025
Reporter Type Manufacturer
Report Source Health Professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 03/14/2025
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
Device Catalogue Number24951
Device Lot Number459946
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date02/17/2025
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 02/17/2025
Initial Report FDA Received Date03/14/2025
Usage of Device A
Patient Sequence Number1
Patient SexUnknown
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