SureLOK MIS 3L 63-4100-55Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840019920063), received between Jan 5, 2021 and Jan 5, 2021 — classified as 1 injury.

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.

• InjuryJan 5, 2021Break

  IT WAS REPORTED THAT A 1 LEVEL TLIF PROCEDURE WAS PERFORMED ON (B)(6)2020, UTILIZING THE SURELOK MIS 3L SYSTEM. SCREW PLACEMENT STARTED BY TARGETING WITH A JAMSHIDI NEEDLE, THERE WAS SOME DIFFICULTY ENCOUNTERED GETTING THROUGH THE FACET, PEDICLE AND INTO THE VERTEBRAL BODY, BUT WIRES WERE PLACED SUCCESSFULLY IN L4 & L5. WHEN TAPPING THE L4 WITH A PALM HANDLE UNDER FLUOROSCOPY, THE TAP AND HANDLE MADE AN AUDIBLE NOISE, AND AT THIS POINT THE FLUOROSCOPY IMAGE IDENTIFIED THAT THE TAP, AWL-INONE, PERC 5.5 MM (63-4100-55) HAD SHEARED OFF. THE SURGEON USED A TUBE RETRACTOR TO DILATE, DRILLED WITH A TREPHINE AND A REVERSE BROKEN SCREW ATTACHMENT WAS USED TO REMOVE THE BROKEN TIP. THE CASE THEN PROCEEDED AND WAS COMPLETED SUCCESSFULLY USING A COMPETITOR'S CANNULATED TAP, WITH NO PATIENT HARM. THERE WAS A DELAY OF ONE (1) HOUR AS A RESULT OF THE ISSUES ENCOUNTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11118617 ↗