Spine Instruments 03.51.10.0182Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630971226418), received between Nov 6, 2018 and Aug 23, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Solder Joint Fracture” (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 18, 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.

• MalfunctionAug 23, 2019Break; Break

  ONE OF THE FOUR SET PINS AT THE EXTREMITY OF THE INSTRUMENT BROKE DURING DISENGAGEMENT, AFTER REDUCTION STEP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8925186 ↗
• MalfunctionMar 6, 2019Fracture; Solder Joint Fracture; Fracture; Solder Joint Fracture

  DURING SURGERY (SCOLIOSIS T4-L4 WITH MONO AND POLY AXIAL SCREWS) THE SURGEON TRIED SEVERAL TIMES AND WITH DIFFERENT THE TWO-STEP REDUCERS (THERE WERE 10 IDENTICAL INSTRUMENTS INTO THE SET) TO REDUCE THE ROD INSIDE THE SCREWS BUT WITH NO SUCCESS AND WITH STRESS. THE SURGERY WAS COMPLETED CHANGING THE SCREW FROM MONO TO POLY IN ORDER TO FACILITATE THE MANOEUVRE OF REDUCTION AND ALSO BECAUSE THE THREAD OF THE MONOAXIAL SCREW WAS DAMAGED AND IT DIDN'T PERMIT TO CLOSE THE ROD WITH THE SETSCREW AT ALL. DURING THE LAST STEP OF THE SURGERY BEFORE CLOSING THE WOUND, THE SURGEON NOTICED A SMALL PIECE OF METAL IN THE SOFT TISSUE AND HE REMOVED IT. THROUGH X-RAY CONTROL, THE OTHER 4 PIECES WERE NOTICED AND REMOVED. THEY SEEMED TO BE THE PINS OF THE DISTAL PART OF THE TWO-STEP REDUCERS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8394726 ↗
• MalfunctionNov 6, 2018Solder Joint Fracture; Solder Joint Fracture

  DURING SURGERY AT L3-S1, THE SURGEON TRIED TO INSERT THE 6 PEDICLE SCREWS WITH THE TWO-STEP REDUCER ENHANCED. HE WAS ABLE TO INSERT ONLY 1 SET SCREW AND THEN THE PIN OF THE TIP BROKE DURING THE INSERTION AT L4. THE SURGEON DISCOVERED THE BROKEN PIECE DURING THE SURGERY. THE TWO-STEP REDUCER BROKE WHILE THE SURGEON WAS TIGHTENING EITHER LOT 1820670 OR 1820671. NO DEBRIS HAS FALLEN INTO THE PATIENT, THE SURGERY HAS BEEN COMPLETED WITH A BACK-UP INSTRUMENT. BECAUSE OF THIS ISSUE, THE SURGERY WAS PROLONGED OF 15 MINUTES.

  Patient problems: Foreign Body In Patient

  MAUDE report 8041553 ↗