Sagittae 502-030-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00819837020507), received between May 9, 2019 and May 9, 2019 — classified as 1 malfunction.

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.

• MalfunctionMay 9, 2019Break; Off-Label Use; Detachment of Device or Device Component

  A SPINEEX DRIVER INSTRUMENT MALFUNCTIONED DURING SURGERY WHEN USED IMPROPERLY WITHOUT THE REQUIRED SPINEEX 2.25 N*M TORQUE LIMITING HANDLE. DURING STEP 7 OF THE SAGITTAE SURGICAL TECHNIQUE, DR. (B)(6) WAS USING THE SPINEEX SAGITTAE NAKED-DRIVER TO EXPAND THE ANTERIOR AND POSTERIOR SIDES OF THE SAGITTAE IMPLANT INDEPENDENTLY OF ONE ANOTHER. HE WAS USING THE SPINEEX 2.25 N*M TORQUE LIMITING HANDLE TO DO SO. WHEN HE WAS UNABLE TO GET ALL THE DESIRED TORQUE, HE WAS THEN LOOKING FOR OTHER METHODS TO EXPAND THE POSTERIOR SIDE OF THE IMPLANT, HE ASKED FOR A NON-TORQUE LIMITING T-HANDLE NOT PROVIDED BY SPINEEX TO CONNECT TO THE SPINEEX SAGITTAE NAKED-DRIVER IN HOPES OF OBTAINING MORE TORQUE. SPINEEX REPRESENTATIVES REMINDED DR. (B)(6) THAT THE SAGITTAE NAKED-DRIVER WAS NOT INTENDED TO BE USED WITHOUT THE SPINEEX PROVIDED 2.25 N*M TORQUE LIMITING HANDLE. DR. (B)(6) UNDERSTOOD THIS AND STILL REQUESTED FOR THE NON-SPINEEX PROVIDED NON-TORQUE LIMITING T-HANDLE. UPON CONNECTING THE NON-TORQUE LIMITING T-HANDLE TO THE SAGITTAE NAKED DRIVER, HE PROCEEDED TO APPLY A TORQUE IN THE WRONG DIRECTION (COUNTERCLOCKWISE) TO THE POSTERIOR SIDE OF THE IMPLANT. (B)(6) INSTRUCTED HIM HE WAS APPLYING THE TORQ

  Patient problems: Foreign Body In Patient

  MAUDE report 8596566 ↗