NA 05.001.214Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982129833), received between Dec 16, 2021 and Sep 11, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Complete Loss of Power” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Mechanical Jam; Complete Loss of Power

  It was reported that during service and evaluation, it was determined that the AO screw attachment device was frozen/would not move. It was noted in the service order that the device was not working. This event did not occur during surgery. There were no reports of injuries, medical intervention or prolonged hospitalization. The exact date of the event was unknown. However, it was reported that the event occurred in 2026. All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50732120 ↗
• MalfunctionDec 16, 2021Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available; Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED FROM (B)(6) THAT THE AO SCREW ATTACHMENT DEVICE HEAD PART WAS UNSCREWING AND STARTING TO COME OFF. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13017963 ↗