icotec Pedicle System, Nut Screw, Ti 16-57-41000Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07640140431994), received between Sep 29, 2023 and May 31, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• InjuryMay 31, 2026Mechanical Problem

  MFR REPORT #: 3006493760-2026-00003 A PATIENT NOTICED INCREASING PAIN WHICH LED TO A FOLLOW-UP IMAGING (DATE NOT REPORTED) WHERE IT WAS NOTICED THAT NUT SCREWS LOOSENED. A REVISION SURGERY WAS PERFORMED ((B)(6) 2026). DURING THE REVISION IT WAS DETECTED THAT TWO PEDICLE SCREWS WERE BROKEN. THE SURGEON DECIDED TO REPLACE THE PEDICLE SYSTEM. EARLIER ((B)(6) 2023), THE PATIENT HAD IMPLANTED AN ICOTEC PEDICLE SYSTEM WITH A REVISION ON (B)(6) 2024 (MDR NO. (B)(4) WHERE THE SURGEON DECIDED TO IMPLANT A 5.5 MM DIAMETER PEDICLE ROD FROM A THIRD PARTY MANUFACTURER (OFF-LABEL). DURING THIS REVISION THE ROD WAS SECURED IN THE PEDICLE SCREWS USING NEW ICOTEC NUT SCREWS.

  Patient problems: Failure of Implant

  MAUDE report 25345301 ↗
• InjuryMay 31, 2026Mechanical Problem

  MFR REPORT #: 3006493760-2026-00001. A PATIENT WAS IMPLANTED WITH AN ICOTEC PEDICLE SCREW SYSTEM ((B)(6) 2025). POST-SURGERY THREE NUT SCREWS (SET SCREWS) LOOSENED (EXACT DATE WERE NOT REPORTED). X-RAY IMAGING SHOWS THAT THE PEDICLE SYSTEM WAS USED TOGETHER WITH TWO ILIAC SCREWS (FROM AN UNKNOWN MANUFACTURER). A REVISION SURGERY WAS PERFORMED AND IMPLANTS WERE REPLACED ((B)(6) 2026).

  Patient problems: Failure of Implant

  MAUDE report 25344876 ↗
• InjuryApr 10, 2026Detachment of Device or Device Component

  A PATIENT NOTICED INCREASING PAIN WHICH LED TO A FOLLOW-UP IMAGING (DATE NOT REPORTED) WHERE IT WAS NOTICED THAT NUT SCREWS LOOSENED. A REVISION SURGERY WAS PERFORMED (B)(6) 2026). DURING THE REVISION IT WAS DETECTED THAT TWO PEDICLE SCREWS WERE BROKEN. THE SURGEON DECIDED TO REPLACE THE PEDICLE SYSTEM. EARLIER (B)(6) 2023), THE PATIENT HAD IMPLANTED AN ICOTEC PEDICLE SYSTEM WITH A REVISION ON (B)(6) 2024 (MDR NO. ON . WHERE THE SURGEON DECIDED TO IMPLANT A 5.5 MM DIAMETER PEDICLE ROD FROM A THIRD-PARTY MANUFACTURER (OFF-LABEL). DURING THIS REVISION THE ROD WAS SECURED IN THE PEDICLE SCREWS USING NEW ICOTEC NUT SCREWS.

  Patient problems: Failure of Implant

  MAUDE report 24843209 ↗
• InjuryMar 6, 2026Detachment of Device or Device Component

  A PATIENT WAS IMPLANTED WITH AN ICOTEC PEDICLE SCREW SYSTEM ((B)(6) 2025). POST-SURGERY THREE NUT SCREWS (SET SCREWS) LOOSENED (EXACT DATE WERE NOT REPORTED). X-RAY IMAGING SHOWS THAT THE PEDICLE SYSTEM WAS USED TOGETHER WITH TWO ILIAC SCREWS (FROM AN UNKNOWN MANUFACTURER). A REVISION SURGERY WAS PERFORMED AND IMPLANTS WERE REPLACED ((B)(6) 2026).

  Patient problems: Failure of Implant

  MAUDE report 24532096 ↗
• InjuryDec 5, 2023Defective Device; Defective Device

  A PATIENT WAS TREATED WITH THE ICOTEC PEDICLE SYSTEM IN A SURGERY. DURING A POST-OP CHECK 7-10 DAYS AFTER, IT WAS DETECTED THAT SIX OUT OF EIGHT NUT SCREWS HAD LOOSENED. A REVISION SURGERY HAD TO BE CARRIED OUT. THE LOOSENED NUT SCREWS AND THE PEDICLE SCREWS WERE REMOVED AND REVISED.

  Patient problems: Failure of Implant

  MAUDE report 18266154 ↗
• InjurySep 29, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  A PATIENT WAS TREATED WITH THE ICOTEC PEDICLE SYSTEM IN A SURGERY ((B)(6) 2022). DURING A POST-OP CHECK, IT WAS DETECTED THAT FOUR NUT SCREWS HAD LOOSENED. A REVISION SURGERY HAD TO BE CARRIED OUT ((B)(6) 2023). DURING THE REVISION SURGERY, IT WAS REALIZED THAT ONE PEDICLE SCREW HAD BROKEN. THE BROKEN PEDICLE SCREW WAS NOT REMOVED. THE LOOSENED NUT SCREWS WERE REVISED AND THE BROKEN SCREW REMAINED IN THE PATIENT. NO ADDITIONAL LEVEL WAS TREATED.

  Patient problems: Failure of Implant

  MAUDE report 17842817 ↗