DS PrimeTaper 68017260Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07392532269981), received between Nov 7, 2024 and Sep 30, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Manufacturing, Packaging or Shipping Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952609 ↗
• MalfunctionApr 4, 2026Mechanical Jam

  CUSTOMER REPORTED LOSS OF INTERNAL SPRING WITHIN THE DRILL SLEEVE. 2026-03-12 (B)(4): SPRING RING ISSUE ¿ CAPA NUMBER 2025-58. EVENT DEEMED NOT REPORTABLE IN COUNTRIES OTHER THAT THE US AS FOLLOW: EU: IT DOES NOT MEET THE CRITERIA OF A SERIOUS INCIDENT AND REFLECTS A DOCUMENTED INHERENT DEVICE RISK; THE EVENT IS DEEMED NOT REPORTABLE TO THE CA BUT WILL BE DOCUMENTED AND MONITORED THROUGH POST-MARKET SURVEILLANCE. BR: NOT MARKETED/ RELEASED. AU: THE EVENT OCCURRED OVERSEAS. CA: EVENT OCCURRED IN A FOREIGN COUNTRY WITH A CLASS II DEVICE. CN: THE EVENT DID NOT CAUSE A DEATH, NOR SEVERE INJURIES OR COULD HAVE POSSIBLY CAUSED SEVERE INJURIES/DEATH AND NO SERIOUS PUBLIC HEALTH THREAT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24784351 ↗
• MalfunctionApr 4, 2026Mechanical Jam

  CUSTOMER REPORTED LOSS OF INTERNAL SPRING WITHIN THE DRILL SLEEVE. (B)(6) 2026 DIOGP514: SPRING RING ISSUE ¿ CAPA NUMBER 2025-58. EVENT DEEMED NOT REPORTABLE IN COUNTRIES OTHER THAT THE US AS FOLLOW: EU: IT DOES NOT MEET THE CRITERIA OF A SERIOUS INCIDENT AND REFLECTS A DOCUMENTED INHERENT DEVICE RISK, THE EVENT IS DEEMED NOT REPORTABLE TO THE CA, BUT WILL BE DOCUMENTED AND MONITORED THROUGH POST-MARKET SURVEILLANCE. BR: NOT MARKETED/ RELEASED. AU: THE EVENT OCCURRED OVERSEAS. CA: EVENT OCCURRED IN A FOREIGN COUNTRY WITH A CLASS II DEVICE. CN: THE EVENT DID NOT CAUSE A DEATH, NOR SEVERE INJURIES OR COULD HAVE POSSIBLY CAUSED SEVERE INJURIES/DEATH AND NO SERIOUS PUBLIC HEALTH THREAT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24784343 ↗
• MalfunctionMar 30, 2026Mechanical Jam

  IT WAS REPORTED THAT UPON INSPECTION OF THE UNUSED SLEEVE, IT WAS FOUND THAT TWO ISSUES PREVENTED INSERTION INTO THE DRILL; THE PROCEDURE WAS COMPLETED WITH A NEW ITEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24735144 ↗
• MalfunctionFeb 9, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A TOOL MALFUNCTION. THE WIRE OF AN UNUSED SLEEVE CAME OFF; THIS WAS DISCOVERED AFTER ATTACHING IT TO THE INSTRUMENT AND WAS DETERMINED TO HAVE OCCURRED AFTER STERILIZATION AND BEFORE SURGERY. THE SESSION WAS COMPLETED ON THE SAME DAY WITHOUT ANY PROBLEMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24291731 ↗
• InjuryNov 7, 2024Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20628632 ↗