AXSOS 661042SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04546540708762), received between Nov 28, 2016 and Dec 30, 2019 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Slipped” (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 16, 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.

• MalfunctionDec 30, 2019Difficult to Insert; Difficult to Insert

  THE AXSOS LOCKING SCREW DID NOT ADVANCE IN THE DIRECTION OF DRILLING OR TAPPING. IT WAS NOT LOCKED TO THE PLATE. WHEN I OPENED AND INSERTED A NEW ONE, I WAS ABLE TO INSERT IT WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9532679 ↗
• InjuryNov 29, 2016Device Slipped

  THE UPPER LIMB CONSULTANT, REPORTED THAT AN AXSOS III PROXIMAL LATERAL HUMERAL PLATE HAD FAILED/PULLED OFF FROM A PATIENT. THE PATIENT WAS REVISED. IT WAS FURTHER REPORTED THAT HE HAD TORQUE THE LOCKING SCREWS AND THAT HE DID NOT THINK THE BONE WAS OF POOR QUALITY. THE SURGEON WAS UNSURE WHETHER THE PATIENT HAD BEEN COMPLIANT.

  Patient problems: No Code Available

  MAUDE report 6133652 ↗
• InjuryNov 28, 2016Device Dislodged or Dislocated

  THE UPPER LIMB CONSULTANT, REPORTED THAT AN AXSOS III PROXIMAL LATERAL HUMERAL PLATE HAD FAILED/PULLED OFF FROM A PATIENT. THE PATIENT WAS REVISED. IT WAS FURTHER REPORTED THAT HE HAD TORQUE THE LOCKING SCREWS AND THAT HE DID NOT THINK THE BONE WAS OF POOR QUALITY. THE SURGEON WAS UNSURE WHETHER THE PATIENT HAD BEEN COMPLIANT.

  Patient problems: No Code Available

  MAUDE report 6130562 ↗
• InjuryNov 28, 2016Device Slipped

  THE UPPER LIMB CONSULTANT, REPORTED THAT AN AXSOS III PROXIMAL LATERAL HUMERAL PLATE HAD FAILED/PULLED OFF FROM A PATIENT. THE PATIENT WAS REVISED. IT WAS FURTHER REPORTED THAT HE HAD TORQUE THE LOCKING SCREWS AND THAT HE DID NOT THINK THE BONE WAS OF POOR QUALITY. THE SURGEON WAS UNSURE WHETHER THE PATIENT HAD BEEN COMPLIANT.

  Patient problems: No Code Available

  MAUDE report 6130557 ↗