N/A 5482304Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169641617), received between Feb 9, 2025 and May 9, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 9, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT DURING A SPINAL PROCEDURE INVOLVING THE CROSSLINK, THE DRIVER BROKE WHILE ATTEMPTING TO TIGHTEN THE GOLD SCREW WITH THE BREAKOFF DRIVER, AND WAS UNABLE TO LOOSEN SCREWS FOR CROSSLINK REMOVAL. THE CROSSLINK WAS INITIALLY PLACED OVER THE RODS WITH PROVISIONAL TIGHTENING TOOLS, AND THE OLD SCREWS HAD BEEN BACKED OFF TO FACILITATE PLACEMENT. A SEPARATE INSTRUMENT WAS USED TO UNSCREW THE CENTER BLUE SCREW. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE CASE WAS A T7-T11 STABILIZATION CASE. AS THE PRO LOCK DRIVER WAS TIGHTENING THE GOLD SCREW ON THE CROSSLINK, THE GOLD SCREW WASN¿T MOVING. THE GOLD SET SCREW HAD AN ISSUE AND WOULDN¿T ADVANCE. IT WAS UNABLE TO ADVANCE THE SCREW IN THE CROSSLINK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21992920 ↗
• MalfunctionMay 5, 2025Break; Material Deformation; Break; Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR FUSION T10-S2. PREOPERATIVE DIAGNOSIS OF THIS SURGERY WAS REOP DUE TO NEUROLOGICAL SYMPTOMS CAUSED BY BLOOD SPECIES. IT WAS REPORTED THAT THE DRIVER HAS BROKEN. A CRACK WAS FOUND AT THE TIP OF THE PRODUCT, AND WHEN ATTEMPTING TO TURN THE SCREW, IT SLIGHTLY WIDENED AND COULD NOT BE FIXATED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE REASON FOR REPEAT SURGERY: NEUROLOGICAL SYMPTOMS DUE TO POSTOPERATIVE HEMATOMA. THERE WERE NO DEFECTS WITH THE IMPLANT PRODUCTS USED DURING THE INITIAL SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21958517 ↗
• MalfunctionFeb 9, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A L5/S1 PLIF PROCEDURE IN A PATIENT DIAGNOSED WITH LUMBAR SPINAL STENOSIS. IT WAS REPORTED THAT THE SCREW COULD NOT BE SCREWED BECAUSE OF IDLING DURING THE FINAL FASTENING OF THE CROSS-LINK SET SCREW. BOTH SIDES WERE TESTED, BUT IT WAS THE SAME. THE DRIVER AND HANDLE WERE REPLACED WITH DIFFERENT ONES AND THEN THE TWO COULD BE FASTENED. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21340947 ↗