Nextra Hammertoe Correction System NX-3532K-SCRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00817701020059), received between Mar 14, 2019 and Feb 10, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

1 FDA recall record name this device's identifier.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Feb 10, 2022Terminated

   Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery

   Z-0913-2022 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 10, 2021No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A SURGERY WITH THE NEXTRA HAMMERTOE CORRECTION SYSTEM, THE PROXIMAL AND MIDDLE IMPLANTS DID NOT SIT FLUSH ON THE NEXTRA DRIVER. THIS CONDITION DID NOT AFFECT THE SURGERY. THE SURGERY WAS COMPLETED AND THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11309456 ↗
• MalfunctionMar 4, 2020No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A SURGERY ON (B)(6) 2020 USING THE NEXTRA HAMMERTOE CORRECTION SYSTEM, THE PROXIMAL IMPLANT COMPONENT COULD NOT BE DISENGAGED FROM THE DRIVER. A SECOND KIT WAS OPENED TO COMPLETE THE SURGERY. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9786594 ↗
• MalfunctionJan 10, 2020No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A SURGERY WITH THE NEXTRA HAMMERTOE CORRECTION SYSTEM THE PROXIMAL IMPLANT WOULD NOT SIT FLAT ON THE SCREWDRIVER. A SECOND SCREWDRIVER WAS OPENED TO COMPLETE THE SURGERY. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9578284 ↗
• MalfunctionJan 10, 2020No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING AN OPERATION PERFORMED WITH THE NEXTRA HAMMERTOE CORRECTION SYSTEM, THE SURGEON HAD DIFFICULTY MATING THE DISTAL END OF THE NEXTRA DRIVER WITH THE DISTAL IMPLANT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH AN ALTERNATE DRIVER. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9576550 ↗
• MalfunctionMar 14, 2019Mechanical Problem; Device Dislodged or Dislocated; Unintended Movement; Mechanical Problem; Device Dislodged or Dislocated; Unintended Movement

  THE PATIENT UNDERWENT HAMMERTOE SURGERY ON (B)(6) 2019. AFTER SURGERY, X-RAYS SHOWED THE IMPLANT HAD DISLOCATED. THE PATIENT CAME BACK INTO THE DOCTOR'S OFFICE THE FOLLOWING DAY FOR THE SURGEON TO ATTEMPT TO FIX THE DISLOCATION. THIS WAS NOT SUCCESSFUL. THE PATIENT WAS SCHEDULED FOR SURGERY ON (B)(6) 2019, AT WHICH POINT THE SURGEON REMOVED THE DISLOCATED 3.5MM MIDDLE IMPLANT. THE SURGEON IMPLANTED A 4.5 MIDDLE IMPLANT TO REPLACE THE IMPLANT. THIS WAS SUCCESSFUL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8422053 ↗