NA 04.633.347Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034746678), received between Jul 12, 2018 and Apr 19, 2021 — classified as 1 injury, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 19, 2021Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING A L2-PELVIS TRANSFORAMINAL LUMBAR INTERBODY FUSION, THE FINAL TIGHTENING SHAFT FOR THE MATRIX CONSTRUCT WAS SLIPPING. INSPECTION OF THE TIP LOOKS LIKE IT IS STRIPPED. ALTERNATE SHORT SHAFT WAS USED WITH MINIMAL DELAY. ALSO THE MIDDLE CAP OF THE #7 CROSS LINK WAS NOT ABLE TO TIGHTEN DOWN; A DIFFERENT #7 CROSS LINK WAS USED WITH MINIMAL DELAY. THERE WERE FRAGMENTS GENERATED AND REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THE SURGERY WAS DELAYED FOR TWO (2) MINUTES AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. DURING INVESTIGATION OF THE RETURNED DEVICES, IT WAS NOTED BOTH THE COMPONENTS WERE NOT ABLE TO BE ASSEMBLED AS THE TRANSLATION SCREW WAS STUCK IN THE T-ROD AND WAS NOT ABLE TO UNSCREW FROM THE PART, WHICH WOULD HAVE CAUSED A DEVICE INTERACTION ISSUE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11686051 ↗
• InjuryJul 12, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT A REVISION SURGERY OF THE SPINE. THE REVISION WAS INDICATED DUE TO A BREAKAGE OF THE IMPLANTED COBALT-CHROMIUM (COCR) RODS AND NON-UNION AT L4-L5. THE PATIENT UNDERWENT A T10- ILIUM POSTERIOR LATERAL FUSION SURGERY ON (B)(6) 2016 TO CORRECT A SCOLIOSIS AND AN EXPEDIUM SPINE SYSTEM WITH VIPER CORTICAL FIX SCREWS, CASCADIA THORACOLUMBAR (TL) INTERBODIES FROM L2-S1, AND AT L4-L5, A MATRIX SNAP-ON TRANSCONNECTOR WERE IMPLANTED. VIVIGEN WAS USED TO AID IN THE FUSION. THE PATIENT RETURNED TO THE SURGEON ON (B)(6) 2018 COMPLAINING OF PAIN. THE SURGEON OBTAINED COMPUTED TOMOGRAPHY (CT) AND X-RAY IMAGES TO EVALUATE THE PATIENT. HE CONFIRMED THAT THE PATIENT HAD FAILED TO FUSE AT L4-L5 AND BROKE THE COCR ALLOY RODS ON BOTH THE LEFT AND THE RIGHT OF THE LEVELS L4-L5. DURING THE REVISION, THE SURGEON REMOVED THE COCR RODS (2) AS WELL AS THE SNAP-ON TRANSCONNECTOR, WHICH WAS DISCOVERED TO BE BROKEN AS WELL. HE REPLACED THE SCREWS AT L4, L5, S1 ON THE RIGHT AS WELL AS S1/ILIAC SCREW ON THE LEFT. HE INCREASED THE DIAMETER OF THOSE SCREWS TO GAIN SUFFICIENT SCREW PURCHASE. THE SURGEON REMOVED THE SCREWS AT T10 AND LEFT THEM OUT. HE, THEN,

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 7683733 ↗