AXSOS 661024SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540685841), received between Nov 28, 2016 and Jul 7, 2020 — classified as 4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 2020Positioning Failure; Positioning Failure

  IT WAS REPORTED: THE DRILL SLEEVE SEEMED TO BE INSTALLED AT AN ANGLE, AND THE DRILL ENTERED AT AN ANGLE AND DID NOT LOCK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10242178 ↗
• InjuryJan 5, 2017Appropriate Device Problem Term/Code Not Available

  THE UPPER LIMB CONSULTANT, REPORTED THAT AN 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 TORQUED 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. ORIGINAL FRACTURE LEFT PROXIMAL HUMERAL SHAFT (B)(6) 2015. TYPICAL NONUNION. ENDS FRESHENED. ROUTINE FOLLOW-UP. PATIENT REPRESENTED ON (B)(6) 2016 WITH PLATE PULLED OFF. SURGEON HAS CONFIRMED THAT THE PATIENT WAS INITIALLY TREATED NONOPERATIVELY IN A BRACE AND DEVELOPED A NONUNION.

  Patient problems: Failure of Implant

  MAUDE report 6226037 ↗
• InjuryJan 5, 2017Loss of or Failure to Bond; Device Slipped; Device Operates Differently Than Expected

  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 TORQUED 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. ORIGINAL FRACTURE LEFT PROXIMAL HUMERAL SHAFT (B)(6) 2015. TYPICAL NONUNION. ENDS FRESHENED. ROUTINE FOLLOW-UP. PATIENT REPRESENTED ON (B)(6) 2016 WITH PLATE PULLED OFF. SURGEON HAS CONFIRMED THAT THE PATIENT WAS INITIALLY TREATED NONOPERATIVELY IN A BRACE AND DEVELOPED A NONUNION.

  Patient problems: No Code Available

  MAUDE report 6225106 ↗
• 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 6133651 ↗
• 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 6130565 ↗