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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY IMPLANTS MANUFACTURING GMBH ANK REG C/ABUT GH 1,5 A 0; IMPLANT, ENDOSSEOUS, ROOT-FORM
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DENTSPLY IMPLANTS MANUFACTURING GMBH ANK REG C/ABUT GH 1,5 A 0; IMPLANT, ENDOSSEOUS, ROOT-FORM Back to Search Results
Catalog Number 17-3060
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 04/21/2024
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
ANK REG C/ABUT GH 1,5 A 0
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
7178457511
MDR Report Key19592746
Report Number3013111692-2024-18571
Device Sequence Number8493393
Product Code DZE
UDI-Device Identifier07392532217593
UDI-Public07392532217593
Combination Product (Y/N)N
Initial Reporter CountryCH
PMA/510(K) Number
K083805
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2023
Device Explanted Year2024
Reporter Type Manufacturer
Report Source Foreign,Health Professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 06/24/2024
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 Number17-3060
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date06/19/2024
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/19/2024
Initial Report FDA Received Date06/24/2024
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Usage of Device A
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
IMPLANT 1.PRODUCT NO.31010425.
Outcome Attributed to Adverse Event Required Intervention;
Patient SexUnknown
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