SureLOK MIS 3LRecalls & reported problems across all models
Precision Spine, Inc. · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 23
- Deaths reported
- 0
- Injuries reported
- 12
- Recalls
- 0
We found 5 models of SureLOK MIS 3L by Precision Spine, Inc. in the FDA's device registry (GUDID). Together they are named in 23 adverse event reports in the FDA's MAUDE database, received between Oct 17, 2019 and May 22, 2026 — classified as 12 injuries, 11 malfunctions.
The most frequently reported specific device problem is “Break” (13 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported SureLOK MIS 3L problems
Device problems
- Break13
- Fracture3
- Detachment of Device or Device Component2
- Difficult to Remove2
- Positioning Failure2
- Connection Problem1
- Defective Component1
- Entrapment of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions16
- Insufficient Information2
- Foreign Body In Patient1
- Laceration(s)1
- No Code Available1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
SureLOK MIS 3L models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SureLOK MIS 3L 63-SP-9005Orthopedic Manual Surgical Instrument18 reports
- SureLOK MIS 3L 63-CP-6540Orthosis, Spondylolisthesis Spinal Fixation2 reports
- SureLOK MIS 3L 63-CP-6545Orthosis, Spinal Pedicle Fixation1 report
- SureLOK MIS 3L 63-9012Screwdriver1 report
- SureLOK MIS 3L 63-4100-55Tap, Bone1 report
Recent SureLOK MIS 3L adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 22, 2026Fracture
IT WAS REPORTED THAT THE SL ROD INSERTER BROKE DURING A PROCEDURE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25262204 ↗InjuryDec 1, 2023Break; Break
IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED BY ON (B)(6) 2023, IN SAUDI ARABIA, UTILIZING THE SURLOK MIS 3L PEDICLE SCREW SYSTEM. AFTER INSERTING THE SCREW, WHILE PULLING THE PERC SCREWDRIVER, SHORT (63-9012) OUT, IT GOT BROKEN AND SMALL PIECES STAYED IN THE PATIENT. THE SURGEON HAD TO MAKE AN INCISION TO TAKE IT OUT PRIOR TO CLOSURE AND AS A RESULT THERE WAS A FORTY (40) MINUTE DELAY TO THE PROCEDURE. THIS OCCURRED ON THE FINAL SCREW SO NO ADDITIONAL INSTRUMENTATION WAS REQUIRED FOLLOWING THE MALFUNCTION OF THE DRIVER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18251243 ↗MalfunctionSep 26, 2023Break; Break
IT WAS REPORTED THAT THE CL ROD INSERTER (63-SP-9005) BROKE DURING SURGERY. FOLLOW-UP ATTEMPTS TO OBTAIN DETAILS HAVE BEEN UNSUCCESSFUL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17819719 ↗InjuryJun 9, 2023Fracture; Fracture
IT WAS REPORTED THAT A REVISION PROCEDURE WAS PERFORMED TO ADDRESS A SURE-LOK MIS TRIPLE LEAD SCREW 6.5MM X 45 MM (63-CP-6545) THAT FAILED POST OPERATIVELY. THE SCREW BROKE JUST UNDER THE HEAD. NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17098979 ↗MalfunctionJun 2, 2023Fracture; Fracture
IT WAS REPORTED THAT THE CENTER LOAD ROD INSERTER MIS 3L (63-SP-9005) BROKE DURING A PROCEDURE. MULTIPLE ATTEMPTS TO OBTAIN DETAILS WERE UNSUCCESSFUL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17050662 ↗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 ↗MalfunctionNov 22, 2022Break; Entrapment of Device
IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON AUGUST 20, 2022, IN (B)(6), UTILIZING THE SURELOK MIS 3L PEDICLE SCREW SYSTEM. DURING THE PROCEDURE AFTER THE ROD WAS INSERTED AND THE LOCK SCREWS TIGHTENED, UPON ATTEMPTS TO LOOSEN THE CL ROD INSERTER (63-SP-9005) TO RELEASE THE ROD IT DID NOT RELEASE. WHILE MANIPULATING THE INSERTER FOR REMOVAL THE TIP BROKE. THE BROKEN TIP WAS REMOVED, AND THE PROCEDURE WAS COMPLETED UTILIZING THE SECOND INSERTER READILY AVAILABLE IN THE SET. AS A RESULT, THERE WAS A 15-30-MINUTE DELAY TO THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15845853 ↗InjuryJul 26, 2022Break
IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON (B)(6) 2022, UTILIZING THE SURELOK MIS 3L PEDICLE SCREW SYSTEM. WHILE ATTEMPTING TO INSERT THE SECOND ROD, THE TIP OF THE CL ROD INSERTER (63-SP-9005) BROKE. THE DOCTOR HAD TO MAKE A LARGER WILTSE INCISION, AND THE BROKEN PIECE WAS REMOVED WITH FORCEPS AND THE ROD WAS INSERTED USING A ROD INSERTER PULLED FROM ANOTHER INSTRUMENT TRAY. THERE WAS NO PATIENT INJURY REPORTED, BUT A FIFTEEN-MINUTE (15) DELAY DUE TO THE MALFUNCTION OF THE ROD INSERTER.
Patient problems: Laceration(s)
MAUDE report 15103272 ↗MalfunctionMay 6, 2022Break
IT WAS REPORTED THAT DURING A 2-LEVEL TLIF PROCEDURE, PERFORMED ON AN UNKNOWN DATE, THE CL ROD INSERTER (63-SP-9005) BROKE DURING FINAL TIGHTENING OF THE LAST LOCK SCREW. THE TIP WAS RECOVERED AND DISCARDED BY SURGICAL STAFF AND THE PROCEDURE WAS COMPLETED UTILIZING A BACKUP ROD INSERTER. THEY WAS NO DELAY TO THE PROCEDURE OR HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14305033 ↗InjuryJun 28, 2021Break; Difficult to Remove
IT WAS REPORTED THAT A TLIF L4-L5 PROCEDURE WAS PERFORMED ON (B)(6) 2021, IN DUBAI. WHILE PLACING THE SECOND ROD, AFTER THE SIX (2) SCREWS AND THE FIRST ROD, THE SURGEON WAS TRYING TO INSERT THE ROD THROUGH THE SCREWS WHEN THE CL ROD INSERTER (63-SP-9005) TIP BROKE INSIDE THE PATIENT AND WAS NO LONGER HOLDING THE ROD. THE SURGEON MANAGED TO INSERT THE LOCKING CAP ON ONE OF THE SCREW TO HOLD THE ROD IN PLACE. ATTEMPTS TO REMOVE THE BROKEN TIP WERE UNSUCCESSFUL. THERE WAS A DELAY TO THE PROCEDURE OF APPROXIMATELY THRITY (30) MINUTES.
Patient problems: Foreign Body In Patient
MAUDE report 12080503 ↗InjuryMay 3, 2021Break
IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON (B)(6), 2021, UTILIZING THE SURLOK MIS 3L PEDICLE SCREW SYSTEM. THE ROD HAD BEEN INSERTED AND THE LOCKING CAPS PLACED AND TORQUED WHEN THE TIP OF THE CL ROD INSERTER ((B)(6)) BROKE OFF. THE BROKEN TIP WAS REMOVED USING HEMOSTATS, AND THE PROCEDURE COMPLETED SUCCESSFULLY WITH NO PATIENT INJURY OR DELAY.
Patient problems: Insufficient Information
MAUDE report 11764378 ↗MalfunctionApr 12, 2021Detachment of Device or Device Component
IT WAS REPORTED THAT A ONE-LEVEL PROCEDURE WAS PERFORMED ON (B)(6) 2021, UTILIZING THE SURELOK MIS 3L PERCUTANEOUS SCREW SYSTEM . WHEN THE SCRUB TECH TRIED TO TIGHTEN THE ROD ONTO THE INSERTER ON THE BACK TABLE, THE TIP OF THE INSERTER BROKE OFF. ANOTHER INSERTER WAS READILY AVAILABE TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH NO DELAY OR ISSUE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11649736 ↗MalfunctionMar 8, 2021Break
A PROCEDURE WAS PERFORMED IN SAUDI ARABIA ON (B)(6) 2021, UTILIZING THE SURELOK MIS 3L PEDICLE SCREW SYSTEM. WHILE INSERTING THE ROD THE CL ROD INSERTER (63-SP-9005) TIP BROKE. THE PROCEDURE WAS COMPLETED UTILIZING A COMPETITOR'S ROD INSERTER. THERE WAS NO PATIENT INJURY BUT A FIFTEEN (15) MINUTE DELAY TO THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11440542 ↗MalfunctionMar 8, 2021Defective Component
IT WAS REPORTED FROM SAUDI ARABIA THAT THE CL ROD INSERTER (63-SP-9005) IS NOT HOLDING THE ROD IN THE INSERTER PROPERLY. THE GOLD KNOB IS NOT FUNCTIONING AS INTENDED. IT WAS NOT INDICATED THAT THIS CAUSED ANY ISSUES DURING A PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11440437 ↗
Other Precision Spine, Inc. products
All Precision Spine, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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