NA 03.611.031Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034713847), received between Oct 2, 2018 and Oct 2, 2018 — 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.

• MalfunctionOct 2, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT, WITH ADJACENT LEVEL DISC DISEASE, UNDERWENT A SPINE REVISION PROCEDURE ON (B)(6) 2018, TO REMOVE SYNTHES USS (UNIVERSAL SPINAL SYSTEM) PEDICLE SCREWS AS THE ORIGINAL LEVEL L5 - S1 HAD FUSED. THE SURGEON REVISED THE PATIENT TO EXTEND FUSION ONE LEVEL ABOVE THE ALREADY FUSED L5-S1 LEVEL. WHILE THE SURGEON WAS ATTEMPTING TO BACK OUT THE PEDICLE SCREW WITH GENERAL SCREW REMOVAL INSTRUMENTS, THE TIP OF A 2.5MM SET SCREW EXTRACTOR BROKE OFF IN THE PEDICLE SCREW. THE SURGEON WAS ABLE TO REMOVE THE SCREW WITH VICE GRIPS WITHOUT ANY ADDITIONAL MEDICAL INTERVENTION BEING REQUIRED. THE SURGEON REMOVED THE 6.0MM TITANIUM SIDE-OPENING SCREW 45 MM (X2) AND THE 6.0MM TITANIUM SIDE-OPENING SCREWS 50MM (X2). THE EXPLANTED SCREWS WERE DISCARDED. ALL FRAGMENTS WERE SUCCESSFULLY REMOVED AND THE PATIENT OUTCOME WAS REPORTED TO BE "GOOD" AT THE END OF THE PROCEDURE. CONCOMITANT DEVICES REPORTED: 6.0MM TITANIUM SIDE-OPENING SCREW 45MM (PART# 498.645, LOT# UNKNOWN, QUANTITY# 2), 6.0 MM TITANIUM SIDE-OPENING SCREW 50MM (PART# 498.650, LOT# UNKNOWN, QUANTITY# 2). THIS REPORT CAPTURES INTRAOPERATIVE BREAKAGE OF SET SCREW EXTRACTOR. THIS REPORT IS FOR ONE (1) 2.5MM SET SCREW

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7927722 ↗