SureLOK MIS 3L 63-CP-6540Recalls & reported problems
Precision Spine, Inc. · Pedicle Screw Ø6.5 x 40mm · Class 2 · Implant
All models of SureLOK MIS 3L (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840019905503), received between Mar 14, 2023 and Mar 14, 2023 — classified as 2 injuries.
The most frequently reported specific device problem is “Positioning Failure” (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
Device problems
- Positioning Failure2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 14, 2023Positioning Failure
IT WAS REPORTED THAT A 3 LEVEL MIS TLIF CAGE PROCEDURE WAS PERFORMED IN JORDAN, UTILIZING THE SURLOK MIS 3L PEDICLE SCREW SYSTEM. AFTER FULL INSERTION OF THE SURE-LOK MIS TRIPLE LEAD SCREW 6.5MM X 40 MM (63-CP-6540) WHILE APPLYING THE ROD/BLOCKER THE SCREW SUDDENLY PULLED OUT OF THE BONE. INFORMATION PROVIDED INDICATES THAT THE PATIENT'S BONE STOCK WAS GOOD AND IS NOT OSTEOPEROTIC. A NEW SCREW WAS THEN IMPLANTED SUCCESSFULLY. THERE WAS A DELAY TO THE PROCEDURE BUT UNKNOWN HOW LONG.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16541876 ↗InjuryMar 14, 2023Positioning Failure
IT WAS REPORTED THAT A MIS TLIF CAGE PROCEDURE WAS PERFORMED IN JORDAN, UTILIZING THE SURLOK MIS 3L PEDICLE SCREW SYSTEM. AFTER FULL INSERTION OF THE SURE-LOK MIS TRIPLE LEAD SCREW 6.5MM X 40 MM (63-CP-6540), WHILE APPLYING THE ROD/BLOCKER THE SCREW SUDDENLY PULLED OUT OF THE BONE. INFORMATION PROVIDED INDICATES THAT THE PATIENT'S BONE STOCK WAS GOOD AND IS NOT OSTEOPOROTIC. A NEW 7.5 X 45MM SCREW WAS THEN IMPLANTED SUCCESSFULLY. THERE WAS A DELAY TO THE PROCEDURE BUT UNKNOWN HOW LONG.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16541873 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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