Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB) IMPLANT DRIVER EV (L) WD GS; ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB) IMPLANT DRIVER EV (L) WD GS; ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS Back to Search Results
Catalog Number 68017003
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 06/11/2026
Type of Reportable Event Malfunction
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
IMPLANT DRIVER EV (L) WD GS
Common Device Name
ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS
Manufacturer (Section D)
DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB)
aminogatan 1
molndal vastra gotalands lan [ S-431 21
SW  S-431 21
Manufacturer (Section G)
DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB)
aminogatan 1
molndal vastra gotalands lan [ S-431 21
SW   S-431 21
Manufacturer Contact
dan eagar
221 west philadelphia st.
york, PA 17401
7178457511
MDR Report Key25811199
Report Number9612468-2026-03580
Device Sequence Number10534912
Product Code NDP
UDI-Device Identifier07392532268953
UDI-Public07392532268953
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2026
Device Explanted Year2026
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source Health Professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 07/14/2026
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Catalogue Number68017003
Device Lot Number1897791
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/22/2026
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date06/22/2026
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/22/2026
Initial Report FDA Received Date07/14/2026
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Is the Device Labeled for Single Use? (Y/N) No
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Reuse
Patient Sequence Number1
Patient SexUnknown
-
-