AXSOS 661002SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327283723), received between Apr 25, 2018 and Jul 7, 2021 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 7, 2021Material Deformation; Material Deformation

  THE CUSTOMER REPORTED TO SALES REP THAT : " ON (B)(6), THE SURGEON PLACED 2 DALL-MILES 6704-0-510, 3 PLUGS 661002S AND AN AXSOS TITANIUM PLATE 627573S ON A TOTAL HIP PROSTHETIC FRACTURE. ON (B)(6), THE PATIENT WAS TAKEN BACK: THE PLUGS WERE NOT ADAPTED: BROKEN? OR OPEN? " SALES REP SAID : "AN INCIDENT FOLLOWING AN AXSOS PLATE INSTALLATION WITH DALL MILES PLUGS AND STRAPPING CABLES. THE PLUGS ARE DEFORMED AND THE CABLE BROKE." ADDITIONAL INFORMATION: THE DALL-MILES CABLE DID NOT BREAK, BUT WAS INTENTIONALLY CUT BY THE SURGEON DURING REMOVAL.

  Patient problems: Failure of Implant

  MAUDE report 12127889 ↗
• InjuryJul 7, 2021Material Deformation; Material Deformation

  THE CUSTOMER REPORTED TO SALES REP THAT ON MARCH 21, THE SURGEON PLACED 2 DALL-MILES 6704-0-510, 3 PLUGS 661002S AND AN AXSOS TITANIUM PLATE 627573S ON A TOTAL HIP PROSTHETIC FRACTURE. ON JUNE 7, THE PATIENT WAS TAKEN BACK: THE PLUGS WERE NOT ADAPTED: BROKEN? OR OPEN? SALES REP SAID: "AN INCIDENT FOLLOWING AN AXSOS PLATE INSTALLATION WITH DALL MILES PLUGS AND STRAPPING CABLES. THE PLUGS ARE DEFORMED AND THE CABLE BROKE." ADDITIONAL INFORMATION: THE DALL-MILES CABLE DID NOT BREAK, BUT WAS INTENTIONALLY CUT BY THE SURGEON DURING REMOVAL.

  Patient problems: Failure of Implant

  MAUDE report 12127878 ↗
• InjuryJul 7, 2021Material Deformation; Material Deformation

  THE CUSTOMER REPORTED TO SALES REP THAT : " ON (B)(6), THE SURGEON PLACED 2 DALL-MILES 6704-0-510, 3 PLUGS 661002S AND AN AXSOS TITANIUM PLATE 627573S ON A TOTAL HIP PROSTHETIC FRACTURE. ON (B)(6), THE PATIENT WAS TAKEN BACK: THE PLUGS WERE NOT ADAPTED: BROKEN? OR OPEN? " SALES REP SAID : "AN INCIDENT FOLLOWING AN AXSOS PLATE INSTALLATION WITH DALL MILES PLUGS AND STRAPPING CABLES. THE PLUGS ARE DEFORMED AND THE CABLE BROKE." ADDITIONAL INFORMATION: THE DALL-MILES CABLE DID NOT BREAK, BUT WAS INTENTIONALLY CUT BY THE SURGEON DURING REMOVAL.

  Patient problems: Failure of Implant

  MAUDE report 12127874 ↗
• MalfunctionApr 25, 2018Component Falling

  THE STRYKER SALES REP REPORTED THAT THE SURGEON WAS USING AN AXSOS III CABLE PLUG AND A NON-STRYKER BEADED WIRE. AS HE WAS FEEDING THE WIRE THROUGH THE CP PLATE THE SURGEON DID NOT HAVE A SINGLE SIDED TENSIONER AND AS SUCH HE COULDN'T GET TENSION QUICKLY. THE CABLE PLUG FELL OUT INTO THE PATIENT. THE DEVICE FELL NEAR THE PROXIMAL FEMUR, CLOSE TO THE PLATE AND COULD NOT BE LOCATED, SO THE SURGEON CHOSE TO LEAVE IT IN THE PATIENT. THE CASE WAS COMPLETED BUT THERE WAS AN 8 MINUTE DELAY TO SURGERY. THE SURGEON HAD CHECKED THE KIT PRIOR TO THE CASE AND WAS AWARE IN ADVANCE OF THE CASE THAT THE CONFIG DID NOT CARRY A SINGLE SIDED TENSIONER.

  Patient problems: Foreign Body In Patient

  MAUDE report 7462966 ↗