SureLOK MIS 3L 63-SP-9005Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00840019920179), received between Oct 17, 2019 and May 22, 2026 — classified as 7 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 18 most recent of 18 reports, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionFeb 22, 2021Difficult to Remove

  IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED UTILIZING THE SURELOK MIS 3L SYSTEM. THE FIRST ROD WAS LOADED NORMALLY ON TO THE INSERTER AND THEN SUCCESSFULLY IMPLANTED USING THE INSERTER. THE SURGEON HAD DIFFICULTY REMOVING THE INSERTER FROM THE ROD USING THE GREEN TORQUE LIMITED DRIVER, BUT ULTIMATELY WAS ABLE TO FREE IT WITH NO NEGATIVE IMPACT TO THE PATIENT OR IMPLANTS. ON THE BACK TABLE THE SCRUB TECH NOTED THAT THE GOLD NOB ON THE INSERTER WAS NOT TURNING. THEY USED STERILE INSTRUMENTS TO TRY TO TURN THE KNOB, BUT WERE UNABLE TO GET ANY MOVEMENT. THE SECOND ROD WAS IMPLANTED USING A NORMAL OPEN ROD INSERTER, NO ATTEMPT TO USE THIS PART WAS MADE AGAIN. THERE WAS NO INJURY TO THE PATIENT OR DELAY TO THE PROCEDURE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11359694 ↗
• InjuryJan 4, 2021Break; Detachment of Device or Device Component

  A 3-LEVEL MIS POSTERIOR FIXATION PLUS FUSION PROCEDURE WAS PERFORMED ON (B)(6) 2020 IN (B)(6), UTILIZING THE SURE-LOK MIS 3L SYSTEM. WHEN THE SURGEON WAS "PUNCHING" ON THE CAGE TO LOCATE IT IN ITS POSITION, THE TLIF CAGE PEEK 8MM X 30MM (TLIF30-08P) BROKE INSIDE THE PATIENT. THE SURGEON WAS ABLE TO REMOVE THE BROKEN CAGE AND ANOTHER WAS INSERTED SUCCESSFULLY. AFTER PLACING CAGES AND BEGINNING TO FIX THE SCREWS, WHILE PLACING THE SECOND ROD, THE SURGEON WAS INSERTING THE LOCK-SCREW, A STRANGE SOUND WAS HEARD, AND IT WAS FOUND THAT THE TIP OF THE CL ROD INSERTER (63-CL-9005) WAS BROKEN OFF. THE BROKEN PIECE WAS REMOVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS THE ROD WAS ALREADY IN PLACE. THERE WAS NO PATIENT HARM REPORTED, BUT THERE WAS A ONE (1) HOUR DELAY TO THE PROCEDURE AS A RESULT OF THESE MALFUNCTIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11108460 ↗
• InjuryNov 23, 2020Break

  INFORMATION PROVIDED INDICATES THAT A PROCEDURE WAS PERFORMED ON (B)(6) 2020, UTILIZING THE SURELOK MIS 3L PEDICLE SCREW SYSTEM. THE ROD WAS ASSEMBLED ONTO THE INSERTER AND THE SURGEON WAS THREADING IT THROUGH THE MIS SCREW TOWERS AND ON ITS WAY DOWN TO SEAT IT, THE CL ROD INSERTER (63-SP-9005) BROKE UPON MANEUVERING. THE TIP WAS RECOVERED AND THE ROD WAS SUCCESSFULLY PLACED USING A KOCHER. THERE WAS A THIRTY (30) MINUTE DELAY TO THE PROCEDURE DUE TO HAVING TO RETRIEVE THE BROKEN TIP AND USE THE KOCHER FOR ROD INSERTION.

  Patient problems: Insufficient Information

  MAUDE report 10886894 ↗
• MalfunctionNov 12, 2020Connection Problem

  INFORMATION PROVIDED INDICATES THAT A PROCEDURE WAS PERFORMED ON (B)(6) 2020 UTILIZING THE SURE-LOK MIS 3L PEDICLE SCREW SYSTEM. DURING THE PROCEDURE THE FIRST ROD HAD BEEN INSERTED USING THE CL ROD INSERTER (63-SP-9005), AFTER THE INSERTER WAS REMOVED FROM THE ROD IT WAS NOTED THAT THE GOLD KNOB WAS LOCKED IN THE OPEN POSITION AND WOULD NOT ATTACH TO THE SECOND ROD. ANOTHER INSERTER WAS READILY AVAILABLE IN ANOTHER SET AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT ISSUE OR SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10830217 ↗
• InjuryJul 27, 2020Break

  A TWO-LEVEL PROCEDURE WAS PERFORMED IN SAUDI ARABIA, ON (B)(6) 2020 UTILIZING THE SURELOK MIS 3L PEDICAL SCREW SYSTEM. WHILE ATTEMPTING TO INSERT THE FIRST ROD, THE TIP OF THE CL ROD INSERTER (63-SP-9005) BROKE. THE BROKEN TIP WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED UTILIZING AN INSERTER FROM ANOTHER SYSTEM. THERE WAS NO REPORTED DELAY TO THE PROCEDURE.

  Patient problems: No Code Available

  MAUDE report 10329515 ↗
• InjuryJul 27, 2020Break

  IT WAS REPORTED THAT DURING A PROCEDURE PERFORMED (B)(6) 2020, THE DOCTOR HAND TIGHTENED THE L5, S1 SET SCREWS ON THE PATIENT'S LEFT SIDE USING THE CAP SCREW INSERTER AND RATCHETING PALM HANDLE. WITH THE ROD INSERTER STILL ATTACHED TO THE ROD, THEY HEARD A POP WHILE HAND TIGHTENING THE SET SCREW ON L4. THEY REALIZED THAT THE ROD INSERTER HAD BROKEN OFF IN-SITU AND CONFIRMED IT VIA FLUORO. THEY WERE ABLE TO FISH OUT THE BROKEN PIECE OF THE INSERTER AND FINISH UP THE SURGERY WITHOUT ANY OTHER FURTHER ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10326827 ↗
• MalfunctionOct 17, 2019Physical Resistance/Sticking

  IT WAS REPORTED THAT AN ALIF 360 PROCEDURE WAS PERFORMED ON (B)(6) 2019, UTILIZING THE SURLOK MIS 3L PEDICLE SCREW SYSTEM. DURING THE PROCEDURE THE SL ROD INSERTER WAS RETRIEVED AND THE SCRUB TECH TRIED TO ENGAGE THE ROD INTO THE INSERTER WITHOUT SUCCESS. THE 3.5MM HEX DRIVER WAS SEATED AND AN ATTEMPT TO TURN THE GOLD KNOB FOUND IT TO BE STUCK. THE SURGEON ATTEMPTED TO FREEHAND LOOSEN IT AND ALSO ATTEMPTED WITH A WRENCH/PLIERS BUT STILL WAS UNABLE TO LOOSEN THE KNOB. THE PROCEDURE WAS COMPLETED BY THE DOCTOR UTILIZING WAX TO HOLD THE ROD STEADY IN THE INSERTER. THERE WAS NO PATIENT INJURY AND A DELAY OF PROCEDURE OF APPROXIMATELY 3-5 MINUTES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9203016 ↗