N/A 5584099Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00643169163065), received between May 15, 2017 and May 12, 2026 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Break” (17 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2026Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL FUSION W ITH TRANSFORAMINAL LUMBAR INTERBODY FUSION. IT WAS REPORTED THAT TIP OF SCREWDRIVER BROKEWHILE TRYING TO INSERT PEDICLE SCREW. HCP DISCARDED BROKEN TIP INTO SHARPS CONTAINER. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25147539 ↗
• MalfunctionJan 21, 2026Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PRODUCT USED FOR POSTERIOR FIX ATION SPINAL PROCEDURE. IT WAS REPORTED THAT THE SCREWDRIVER WAS BROKEN. THE PRODUCT WAS UTILIZED CORRECTLY ACCORDING TO THE INSTRUCTIONS FOR USE. THERE WAS NO PATIENT INVOLVED AND NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED REGARDING THE REPORTED EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE REPORTED PRODUCT WAS ALREADY USED BEFORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24128400 ↗
• MalfunctionJan 19, 2026Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A SCREWDRIVER USED FOR POSTERIOR FIXATION SPINAL THERAPY. IT WAS REPORTED THAT THE SCREWDRIVER WAS BROKEN. NO FRAGMENTS OF THE INSTRUMENT REMAINED IN THE PATIENT. THE BROKEN SCREWDRIVER WAS REPLACED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24107942 ↗
• MalfunctionJul 28, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING REVISION SURGERY FOR THE THE REMOVAL OF THE EXISTING L5 TSRH RP SCREW DUE TO L5/S ADJACENT INTERVERTEBRAL DISORDER, L3/S FIXATION WAS PERFORMED IN CONNECTION WITH L3-5. FOLLOWED BY THE INSERTION OF A NEW SOLERA SCREW ON L5/S TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) WAS PERFORMED. IT WAS REPORTED THAT THE PROCEDURE ENCOUNTERED CHALLENGES DUE TO PEDICLE HARDENING, CAUSING THE TIP OF THE DRIVER TO BREAK DURING SCREW INSERTION. REPLACEMENT DRIVER WERE USED, BUT THAT REPLACEMENT DRIVER ALSO BROKE DURING SCREW REMOVAL. THE SCREW SIZE WAS ADJUSTED FROM 7.5MM TO 6.5MM, AND THE SCREW WAS EVENTUALLY EXTRACTED USING A SHORT ROD AND REVERSE ROTATION WITH A POWER GRIP. THESE ISSUES CAUSED A DELAY OF LESS THAN 60 MINUTES IN THE OVERALL PROCEDURE TIME. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. THE ALLEGATION ON SCREW WAS THE ROD PIECE AND THE SCREW WERE STUCK ON THE DISTAL SIDE OF THE PRODUCT. THE DAMAGED SCREWDRIVER TIP REMAINS IN THE SCREW CROWN. SINCE IT WAS NOT POSSIBLE TO REMOVE OR INSERT WITH A NORMAL SCREWDR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22629162 ↗
• MalfunctionJul 24, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING FIXATION PROCED URE FROM L4 TO S2 FOR L5/S PSEUDOARTHROSIS. IT WAS REPORTED THAT DURING THE FIXATION PROCEDURE FOR THE INITIAL SURGERY (PLIF BETWEEN TWO VERTEBRAE) TO ADDRESS PSEUDOARTHROSIS CAUSED BY A SCREW FRACTURE, THE SCREW ON THE LEFT SIDE AT L4/5/S WAS REMOVED. WHILE ATTEM PTING TO INSERT A NEW SCREW FROM L4 TO S2, THE TIP OF THE DRIVER BROKE. A NEW DRIVER WAS USED, BUT THE SCREW DID NOT MOVE, AND THIS DRIVER ALSO BROKE. THE DAMAGED SCREW WAS ULTIMATELY DESTROYED USING A METAL CUTTER AND REPLACED WITH A DIFFERENT SCREW. THE OVERALL PROCEDURE EXPERIENCED A DELAY OF LESS THAN 60 MINUTES. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED IN RELATION TO THE EVENT. THE ALLEGATION OF THE SCREW WAS, IT BECAME NOT-ROTATING, HENCE IT WAS DESTROYED WITH METAL CUTTER INTENTIONALLY. REGARDING THE INITIAL SURGERY. IT WAS REPORTED THAT A SCREW FROM ANOTHER COMPANY WAS USED, WHICH FRACTURED AND LED TO PSEUDOARTHROSIS. AS A RESULT, REVISION SURGERY WAS PERFORMED TO REMOVE THE FRACTURED SCREW. DURING THIS REVISION SURGERY, WHILE REMOVING THE SCREW FROM THE OTHER COMPA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22589255 ↗
• MalfunctionApr 17, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT, WHEN THE PHYSICIAN PERFORMED INSERTION OF S5 SCREW, A CRACKING SOUND WAS HEARD AND BREAKAGE TO THE SCREWDRIVER WAS CONFIRMED. PROCEDURE/TECHNIQUE PERFORMED WAS POSTERIOR LUMBAR FUSION. DURING THE REVISION SURGERY, THE TIP OF DRIVER BROKE IN THE CROWN OF SCREW. SO THE SCREW WAS REMOVED AND IMPLANTED ANOTHER SCREW. THERE WERE NO FRAGMENTS OF BROKEN DRIVER LEFT INSIDE PATIENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED. NO ADDITIONAL TREATMENT OR SURGERY PERFORMED AS A RESULT. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21855251 ↗
• MalfunctionOct 21, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING MAST TRANSFORAM INAL LUMBAR INTERBODY FUSION/REMOVAL OF INSTRUMENTATION AT L1-L3 FOR ADJACENT LEVEL DISEASE. IT WAS REPORTED THAT THE SCREW WAS STUCK IN L2 PEDICLE AND UNABLE TO ADVANCE OR BACK OUT. BROKE 2 SCREWDRIVER TIP OFF TRYING TO REMOVE THE SCREW. SURGEON DECIDED TO CUT THE SCREW FLUSH AND LEAVE SHANK OF SCREW IN L2 PEDICLE AND PLACE A SCREW AT L3 INSTEAD. SCREWHEAD AND PARTIAL SHANK REMOVED. APPROXIMATELY 35MM IN PATIENT. SCREW PLACED AT ADJACENT LEVEL, NOT ORIGINALLY PLANNED. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20490845 ↗
• MalfunctionJan 31, 2023Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SCREW USING A DRIVER IN A "SOLERA OPEN" PEDICLE SCREW PLACEMENT VIA GUIDEWIRE AT L5-S1 FOR A TERMINAL DEGENERATION L5/S1, AFTER TLIF. IT WAS REPORTED THAT ALTHOUGH THE TOP OF THE SCREWDRIVER BROKE DURING THE PLACEMENT OF THE SCREW, THE SURGEON WAS STILL ABLE TO FINISH SCREW-PLACEMENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S MEDICAL HISTORY INCLUDES CORONARY BYPASSES. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16270404 ↗
• MalfunctionNov 14, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR ADJACENT INTERVERTEBRAL DISORDER. IT WAS REPORTED THAT DRIVER WAS BROKEN AS BONE SUBSTANCE WAS HARD. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15786823 ↗
• MalfunctionNov 17, 2021Break; Break

  INFORMATION WAS RECEIVED, FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE. REGARDING A PATIENT IMPLANTED WITH A SCREW USING A DRIVER IN A POSTERIOR FUSION FOR AN L5/S RADICULAR SYMPTOM. IT WAS REPORTED, THAT THE DRIVER BROKE, DURING SCREW INSERTION. THERE WERE NO FRAGMENTS OF THE DRIVER. AND SCREW REMAINING IN THE PATIENT'S BODY. NEUROLOGICAL SYMPTOM DEVELOPED, AFTER THE INITIAL OPERATION LEADING TO REOPERATION. AT THE TIME OF REOPERATION, THE SCREW PREVIOUSLY IMPLANTED IN L5 WAS LOOSE AND HENCE REMOVED. ANOTHER SCREW WAS INSERTED IN ITS PLACE WITHOUT ADDITIONAL TAPPING WHEN THE DRIVER BROKE. CONSIDERING THE POSSIBILITY, THAT THE SCREW WAS TOO LONG, THEY CHANGED THE SCREW AND REPLACED THE DRIVER AND INSERTED THE SCREW. THE EVENT WAS ASSOCIATED WITH A PATIENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THIS WAS A REVISION SURGERY FOR L5/S RADICULAR SYMPTOM. INITIAL SURGERY TOOK PLACE ON (B)(6) 2019. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN OVERALL PROCEDURE TIME. THERE WAS NO IN-PATIENT HOSPITALIZATION OR PROLONGATION OF EXISTING HOSPITALIZATION NECESSARY. AND NO TREATMENT OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12825925 ↗
• MalfunctionJun 3, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT SPINAL THERAPY FOR COM PRESSION FRACTURE. IT WAS REPORTED THAT IT WAS ATTEMPTED TO TURN THE SET SCREW, AND THE SET SCREW BROKE. THERE WERE NO BROKEN FRAGMENTS LEFT INSIDE THE PATIENT. THERE WAS A DELAY MORE THAN 60 MINUTES. THERE WAS PATIENT INVOLVED IN THE EVENT AND NO SYMPTOMS WERE REPORTED. (B)(6) 2021 E1 (REP): ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE TIP OF THE SCREWDRIVER WAS DAMAGED WHEN ATTEMPTED TO LOOSEN THE SET SCREW AFTER FINAL TIGHTENING WITH THE SCREWDRIVER. THE LOT NUMBER IS UNKNOWN. THIS WAS A PATIENT WHO HAS HAD SURGERY SEVERAL TIMES, AND THE SET SCREW WAS USED IN THE PREVIOUS OPERATION. THE PROCEDURE INVOLVED IS FIXATION EXTENSION. THE PRODUCT CONTACT WAS UNKNOWN. (B)(6) 2021 E3 (REP): ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE SET SCREW IS NOT BROKEN, THE DRI VER TIP WAS BROKEN. THE TIP OF THE DRIVER WAS BROKEN, AND THERE WAS NO BROKEN FRAGMENTS LEFT INSIDE THE PATIENT. THE REPORTED DRIVER WAS USED IN THE REVISION SURGERY AND THE DELAY WAS MORE THAN 60 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11929412 ↗
• MalfunctionMay 17, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH A SPINAL PRODUCT TYPE FOR LUMBAR SPINAL CANAL STENOSIS. IT WAS REPORTED THAT THE TIP OF 4 DRIVERS WAS BROKEN WHEN PEDICLE SCREW WAS INSERTED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THERE WERE NO FRAGMENTS OF THE IMPLANTS OR INSTRUMENTS REMAINED IN THE PATIENT'S BODY. THERE WAS A DELAY OF LESS THAN 60MIN IN OVERALL PROCEDURE TIME. THE SCREW PLACEMENT WAS COMPLETED AND THE OPERATION HAD BEEN COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11830659 ↗
• MalfunctionMay 17, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH A SPINAL PRODUCT TYPE FOR LUMBAR SPINAL CANAL STENOSIS. IT WAS REPORTED THAT THE TIP OF 4 DRIVERS WAS BROKEN WHEN PEDICLE SCREW WAS INSERTED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THERE WERE NO FRAGMENTS OF THE IMPLANTS OR INSTRUMENTS REMAINED IN THE PATIENT'S BODY. THERE WAS A DELAY OF LESS THAN 60MIN IN OVERALL PROCEDURE TIME. THE SCREW PLACEMENT WAS COMPLETED AND THE OPERATION HAD BEEN COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11830639 ↗
• MalfunctionApr 12, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL LUMBAR FUSION AT L4-5. IT WAS REPORTED THAT THE PATIENT HAD VERY HARD BONE AND THE SCREWS WERE CHALLENGING TO INSERT, DURING INSERTION OF THE LEFT L5 SCREW THE TIP OF THE CANNULATED DRIVER BROKE OFF (ABOUT 3MM) IN THE SCREW CANAL. THE PIECE WAS SEATED INTO THE SCREW AND DID NOT IMPEDE CONTINUED INSERTION OF THE SCREW, A SECOND DRIVER WAS USED INSTEAD AND THE PROCEDURE CONTINUED ON WITHOUT ANY FURTHER INCIDENCE. BROKEN TIP REMAINED IN PATIENT. THERE WERE NO PATIENT SYMPTOMS/ COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11647757 ↗
• MalfunctionOct 30, 2020Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH REVISION AND EXTENSION OF A SPONDY INVOLVED IN FUSION THERAPY. LEVELS IMPLANTED: L4/S1 IT WAS REPORTED DURING PROCEDURE, THE SCREWDRIVERS BROKE OFF WHEN INSERTING THE SOLERA SCREWS. IT HAD 2 SCREWDRIVERS IN THE TRAY. THE SECOND SCREWDRIVER ALSO BROKE. THERE WAS NO FRAGMENTS OF BROKEN INSTRUMENT LEFT IN PATIENT'S BODY. EVENT WAS REVISION SURGERY. THE SURGEON REMOVED ALL LEGACY SCREW, NOT RELEVANT FOR THE BROKEN SCREWDRIVER. PRODUCTS WERE REPLACED. THERE WAS NO DELAY IN OVERALL PROCEDURE TIME. THERE IS NO TREATMENT OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF THE EVENT. THERE IS NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THE EVENT. ON (B)(6) 2020, RECEIVED ADDITIONAL INFORMATION THAT PATIENT HAD PAIN, SO REVISION SURGERY WAS PERFORMED. SURGEON REPLACED LEGACY SCREWS WITH SOLERA SCREWS. REPORTED THERE WERE NO PROBLEMS WITH LEGACY SCREWS. REPORTED TWO SCREWDRIVERS BROKE WHEN INSERTING SOLERA SCREWS EVEN WHEN THE PATIENT HAD HARD BONE. PATIENT IS ALIVE AND NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10764334 ↗
• MalfunctionOct 30, 2020Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH REVISION AND EXTENSION OF A SPONDY INVOLVED IN FUSION THERAPY. LEVELS IMPLANTED: L4/S1 IT WAS REPORTED DURING PROCEDURE, THE SCREWDRIVERS BROKE OFF WHEN INSERTING THE SOLERA SCREWS. IT HAD 2 SCREWDRIVERS IN THE TRAY. THE SECOND SCREWDRIVER ALSO BROKE. THERE WAS NO FRAGMENTS OF BROKEN INSTRUMENT LEFT IN PATIENT'S BODY. EVENT WAS REVISION SURGERY. THE SURGEON REMOVED ALL LEGACY SCREW, NOT RELEVANT FOR THE BROKEN SCREWDRIVER. PRODUCTS WERE REPLACED. THERE WAS NO DELAY IN OVERALL PROCEDURE TIME. THERE IS NO TREATMENT OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF THE EVENT. THERE IS NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THE EVENT. ON (B)(6) 2020, RECEIVED ADDITIONAL INFORMATION THAT PATIENT HAD PAIN, SO REVISION SURGERY WAS PERFORMED. SURGEON REPLACED LEGACY SCREWS WITH SOLERA SCREWS. REPORTED THERE WERE NO PROBLEMS WITH LEGACY SCREWS. REPORTED TWO SCREWDRIVERS BROKE WHEN INSERTING SOLERA SCREWS EVEN WHEN THE PATIENT HAD HARD BONE. PATIENT IS ALIVE AND NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10764328 ↗
• MalfunctionMay 15, 2017Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LUMBAR DECOMPRESSION/FUSION AT L2-PELVIS DURING WHICH THE TIP OF THE DRIVER BROKE. DURING INSERTION OF THE ILIAC SCREW IN SCLEROTIC BONE TIP OF THE DRIVER BROKE. NO FRAGMENTS REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATION WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6566196 ↗