NA 1806-6169Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04546540510051), received between Dec 28, 2020 and Sep 29, 2026 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Fracture” (10 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 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935435 ↗
• MalfunctionOct 22, 2025Fracture; Fracture

  AS REPORTED: "THE TIP OF THE CONICAL EXTRACTOR WAS DAMAGED DURING SCREW REMOVAL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23359100 ↗
• MalfunctionMar 6, 2025Break; Fracture; Break; Fracture

  DURING REVISION SURGERY, SCREWDRIVER TIP BROKEN OFF WHILE EXTRACTING AN COMPETITOR SCREW FROM THE PATIENT BODY DUE TO PEDIATRIC GROWTH. SCREW FRACTURE AND ALL DEBRIS WERE REMOVED FROM PATIENT BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21534864 ↗
• MalfunctionFeb 12, 2025Break; Fracture; Break; Fracture

  AS REPORTED: "THE EXTRACTION OF 4.0CCS WAS DIFFICULT, THE SCREW HEAD WAS REMOVED AND A CONICAL EXTRACTOR SMALL WAS USED, BUT THE TIP BROKE OFF AND REMAINED IN THE SCREW. THE INSIDE OF THE CROWN DRILL WAS CLOGGED. FINALLY, ALL EXTRACTION WAS COMPLETED".

  Patient problems: Insufficient Information

  MAUDE report 21368802 ↗
• MalfunctionFeb 12, 2025Break; Fracture; Break; Fracture

  IT WAS REPORTED: "THE TIP WAS BROKEN OFF DURING REMOVAL SURGERY".

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21367558 ↗
• InjuryNov 25, 2024Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT: "DURING A RECENT USE OF THE BROKEN SCREW REMOVAL KIT, THE TIP OF THE 2.5MM LEFT-TURN CONICAL EXTRACTOR (REF. (B)(4) BROKE OFF." (B)(6) 2024 - ADDITIONAL INFORMATION RECEIVED: BREAKAGE DURING SURGERY. PROCEDURE COMPLETED WITH DECISION TO LEAVE SCREW BODY IN BONE WITHOUT SCREW HEAD PREVIOUSLY REMOVED BY (B)(6). NO PATIENT IMPACT, NO CONSEQUENCES FOR THE PATIENT AS THE PROMINENT (AND PAINFUL) SCREW HEAD COULD BE REMOVED. NO DELAY, QUICK DECISION TO LEAVE THE SCREW BODY IN THE BONE.

  Patient problems: Foreign Body In Patient

  MAUDE report 20771023 ↗
• MalfunctionMay 15, 2024Break; Fracture; Break; Fracture

  AS REPORTED: "INTRAOPERATIVE BREAKAGE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19321241 ↗
• MalfunctionMay 22, 2023Break; Fracture; Noise, Audible; Break; Fracture; Noise, Audible

  DURING THE REMOVAL OF A SCREW THE TIP OF THE CONICAL SCREW EXTRACTOR BROKE WHEN TORQUE WAS APPLIED. A NOISE WAS MADE AND INEFFECTIVE REMOVAL OF THE SCREW WAS NOTICED. THERE WAS NO REPORTED DEBRIS AND THE IMPLANT WAS EXTRACTED USING DIFFERENT METHODS (PLIARS AND OSTEOTOME).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16973864 ↗
• MalfunctionSep 1, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING AN EXTRACTION PROCEDURE ALL RODS AND UNBROKEN SCREWS WERE SUCCESSFULLY EXTRACTED. THE SURGEON DECIDED TO USE A CONICAL EXTRACTOR TO REMOVE THE REMAINING SCREW IN THE L1 RIGHT PEDICLE WHICH RESULTED IN THE TIP OF THE CONICAL EXTRACTOR BREAKING OFF INSIDE A ES2 SCREW. THE SURGERY WAS COMPLETED WITH THE BROKEN ES2 SCREW AND THE TIP OF THE CONICAL EXTRACTOR LEFT INSIDE THE BODY.

  Patient problems: Foreign Body In Patient

  MAUDE report 15336502 ↗
• InjuryDec 28, 2020Fracture; Fracture

  THE CUSTOMER REPORTED TO THE SALES REP THAT: "DURING MY LAST INTERVENTION OF THE DAY, I HAD TO TRY TO REMOVE SOME OLD SCREWS FROM A FOOT. DURING THIS ATTEMPT, I FIRST USED THE APPROPRIATE SCREWDRIVER, BUT UNFORTUNATELY THE THREAD DID NOT HOLD AND THIS DAMAGED THE THREAD, MAKING IT IMPOSSIBLE TO REMOVE THEM. I THEN ASKED FOR THE UNIVERSAL EXTRACTION TOOL. THIS TIME I WAS ABLE TO GET A GRIP, BUT THE HARDWARE BROKE. I USED THE SIZE ABOVE, BUT AGAIN THE MATERIAL BROKE. SO I HAD TO CUT THE BONE AROUND THE TREFFIN SCREWS, WHICH MADE THE OPERATION VERY COMPLICATED AND THE RESULT VERY UNCERTAIN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11076950 ↗