NA 388.656Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034773728), received between Sep 29, 2020 and Sep 29, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2020Break; Break

  IT WAS REPORTED DURING A LUMBO SACRAL FUSION AT THE LEVEL OF VERTEBRA L4-L5-S1 PROCEDURE ON (B)(6) 2014, THE TIP OF THE AWL BROKE OFF AND CAUSED A DURAL TEAR. A SMALL QUANTITY OF ISOBETADINE WAS INJECTED IN THE INTRATHECAL SPACE. POST-SURGERY THE PATIENT SHOWS PARESIS OF ¿FOOT LIFTERS¿ 1/5 BILATERAL WITH SENSITIVITY ISSUES IN DERMATOMES L5 AND S1 WITHOUT RADIATING PAIN IN THE LEGS.

  Patient problems: Fatigue; Hypoesthesia; Hyporesponsive to stimuli; Injury; Nerve Damage; No Code Available; Paresis; Unspecified Tissue Injury; Weakness

  MAUDE report 10600930 ↗