FIXOS 658042Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613252707028), received between Jun 27, 2019 and Oct 5, 2021 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 5, 2021Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021 THE PATIENT'S FOOT BECAME VERY RED AND PAINFUL AND SHE HAD A DIFFICULT TIME WALKING. THE PATIENT WENT TO THE EMERGENCY ROOM, AND IT WAS FOUND THE PATIENT HAD A NON-UNION. THE PATIENT WAS HOSPITALIZED FOR 2 DAYS. ON (B)(6), 2021 THE SCREW WAS REMOVED, AND IT WAS FOUND SHE HA NON-UNION AFTER ARTHRODESIS. THE PATIENT WAS RELEASED AND ADVISED TO SAY OFF HER FOOT FOR 8 WEEKS. THE HOSPITAL RETAINED THE SCREW.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Implant Pain; Nonunion/Delayed-union Bone Fracture

  MAUDE report 12579489 ↗
• InjuryOct 5, 2021Fracture; Fracture

  THE PATIENT'S HUSBAND REPORTED THAT HIS WIFE ORIGINALLY HAD SURGERY ON (B)(6), 2018. THE SURGERY WAS FOR TALIPES VALGUS RIGHT HAMMER TOE OF RIGHT FOOT ARTHROPATHY. A SCREW (4X42 MM CATALOG# 658042) WAS IMPLANTED. IN (B)(6) 2019, AN X-RAY SHOWED EVERYTHING WAS OKAY. BETWEEN (B)(6)2021, THE PATIENT STARTED TO HAVE PROBLEMS WITH HER FOOT. ON(B)(6) , 2021 AN X-RAY FOUND THE SCREW HAD FAILED. IT WAS AN INTERVAL FRACTURE OF OF THE NECK OF THE PARTIALLY CANNULATED SCREW TRAVERSING BETWEEN THE FIRST METATARSAL AND MEDIAL CUNEIFORM. ON (B)(6) 2021 THE PATIENT HAD ANOTHER SURGERY ON THAT FOOT. THE SURGERY WAS FOR A BONE SPUR OF THE RIGHT FOOT; THE SURGEON SAID IF THE SCREW WAS EXPOSED HE WOULD REMOVE IT, BUT DID NOT REMOVE IT AT THAT TIME.

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 12579466 ↗
• MalfunctionJun 27, 2019Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE HEAD OF 4.0 FIXOS SCREW BROKE OFF DURING REMOVAL FROM DISTAL TIBIA. REMAINDER OF SCREW WAS RETAINED IN PATIENT. NO ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8739907 ↗