N/A 8110530Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00721902744600), received between Jan 24, 2018 and Oct 15, 2025 — classified as 18 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, 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2025Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REP ORTED THAT THE TORQUE LIMITING DRIVER WAS RUSTY, THE COUNTER TORQUE CROSSLINK AND DRIVER WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE DEVICES WERE USED NUMEROUS TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23287319 ↗
• MalfunctionFeb 11, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A USER FACILITY (UF) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT USED IN UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THE DEVICE WAS BROKEN. THERE IS NO PATIENT INVOLVED IN THE EVENT AND NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21355653 ↗
• MalfunctionFeb 7, 2025Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED FROM MANUFACTURER REPRESENTATIVE STATING, THERE WAS NO MALFUNCTION ASSOCIATED WITH PREVIOUSLY IMPLANTED HARDWARE. REVISION WAS PERFORMED TO EXTEND THE FUSION. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21330649 ↗
• MalfunctionFeb 4, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING REMOVAL OF T11-L1 HARDWARE, T4-L1 FUSION, CONNECTING TO PREVIOUS L1-L5 HARDWARE. IT WAS REPORTED THAT SURGEON WANTED TO REMOVE THE CROSSLINK. WHEN USING THE REPORTED DRIVER, THE TIP OF THE DRIVER BROKE OFF, AND REMAINED IN THE CROSSLINK. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21301799 ↗
• MalfunctionJan 28, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A CROSSLINK AND HEX DRIVER USED IN A DECOMPRESSION AND 2A2B POSTERIOR FIXATION FOR TH2. IT WAS REPORTED THAT CROSS-LINK INSTALLATION WAS PERFORMED AFTER ALL THE SCREWS WERE FINALLY TIGHTENED. AFTER TEMPORARY TIGHTENING, THE FINAL TIGHTENING WAS PERFORMED ON THE LEFT SIDE. THE BREAK-OFF DRIVER WAS IDLING DURING THE FINAL TIGHTENING ON THE RIGHT SIDE. WHEN IT WAS ROTATED IN THE OPPOSITE DIRECTION IN ORDER TO REPEAT THE PROCEDURE AGAIN, IT BROKE OFF AT THAT TIME. WHEN IT WAS ATTEMPTED TO REMOVE THE SET SCREW AFTER THE BREAK-OFF USING 3.0 MM HEX, THE TIP OF THE HEXAGONAL SHAFT BROKE WITHIN THE SET SCREW. WHEN THE SET SCREW OF THE SCREW ITSELF WAS COMPLETELY REMOVED, IT WAS REMOVED ALONG WITH THE ROD, AND THE CROSS-LINK FROM THE ROD JUST CAME OFF. IT WAS UNABLE TO BREAK OFF WHEN THE CROSS-LINK OUTER SET SCREW WAS TIGHTENED. AFTER ATTEMPTING TO REMOVE IT, CROSSLINK BROKE. THE HEXAGONAL PORTION OF THE TIP WAS BROKEN AND REMAINED IN THE CROSS-LINK IN THE SURGICAL FIELD. AFTERWARDS, IT WAS REMOVED FOR THE WHOLE CROSS-LINK AND THERE WERE NO REMAINING IN THE BODY. THE SET SCREW IN THE CROSSLINK

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21251405 ↗
• MalfunctionJan 23, 2025Material Twisted/Bent; Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THE TIP IS BENT. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21215623 ↗
• MalfunctionNov 6, 2024Break; Naturally Worn; Break; Naturally Worn

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (QUALITY INSPECTOR) REGARDING A PART USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE TIP WAS BROKEN AND INSTRUMENT WAS WORN. THERE WAS NO FURTHER INFORMATION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20619941 ↗
• MalfunctionOct 3, 2024Break; Break

  MDR DECISION CORRECTED TO NOT REPORTABLE. NO ADDITIONAL SUPPLEMENTALS REQUIRED UNLESS ADDITIONAL INFORMATION RECEIVED INDICATES REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20358142 ↗
• MalfunctionDec 6, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCTS USED IN REMOVAL OF CROSSLINK SPINAL THERAPY FOR TUMOR RESECTION AND CAGE PLACEMENT. IT WAS REPORTED THAT THE DRIVER WAS BROKEN. THERE WERE NO BROKEN FRAGMENTS LEFT INSIDE THE PATIENT AND NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15922766 ↗
• MalfunctionNov 21, 2022Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT UNDERGOING REMOVAL OF INSTRUMENTATION FOR BURST FRACTURE. IT WAS REPORTED THAT THE DRIVER STRIPPED. THE INSTRUMENT BROKE AND NO FRAGMENT OF THE INSTRUMENT REMAINING IN THE PATIENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15832163 ↗
• MalfunctionMay 13, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING LUMBAR DDD REVISION DUE TO INFECTION. IT WAS REPORTED THAT THE END OF THE INSTRUMENTS BROKE DUE TO THE SET SCREWS BEING TOO TIGHT. THERE WERE NO FRAGMENTS OF THE IMPLANTS OR INSTRUMENTS REMAINED IN THE PATIENT'S BODY. PRODUCT WILL BE RETURNED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14393014 ↗
• MalfunctionOct 12, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH SCREW DEVIATION INVOLVED IN THE L5 SCREW REPLACEMENT. LEVELS IMPLANTED- L2-L5. IT WAS REPORTED THAT INTRA-OPERATIVELY, TIP OF THE DRIVER BROKE. NO FRAGMENTS LEFT IN THE PATIENT'S BODY. AN ATTEMPT WAS MADE TO REMOVE THE PROLOCK FIRST TO REPLACE THE SCREW, BUT THE GOLDEN SET SCREW OF THE PROLOCK STRIPPED ONE PLACE. THEY REMOVED THE SET SCREWS OF PS ON BOTH SIDES AND REMOVED THE PROLOCK ALONG WITH THE ROD. AFTER THE SCREW REPLACEMENT WAS COMPLETED, THE ORIGINAL IMPLANTED ROD AND PROLOCK WERE RESET, AND WHEN THE PROLOCK WAS FINALLY FIXED WITH A 3.0MM HEX DRIVER ACCORDING TO THE MANUAL MAX, TIP OF THE DRIVER BROKE. THE BROKEN DRIVER TIP WAS REMOVED USING AN AIR TOME. THERE WAS DELAY IN OVERALL PROCEDURE TIME FOR LESS THAN 60 MINUTES. EVENT WAS REVISION SURGERY TO EXPLANT THE DEVIATED SCREW. INITIAL SURGERY PROCEDURE WAS PLIF OF 3 INTERVERTEBRAL DISCS AT L2-L5. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO HEALTH DAMAGE IN THE PATIENT WAS REPORTED. ON (B)(6) 2021, RECEIVED ADDITIONAL INFORMATION THAT, IT WAS AN OPERATION FOR REPLACEMENT SINCE THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12615836 ↗
• MalfunctionAug 12, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH UNKNOWN INDICATION INVOLVED IN POSTERIOR SPINAL FUSION PROCEDURE. LEVELS TREATED/IMPLANTED: T4-10. IT WAS REPORTED THAT INTRA-OPERATIVELY, THE DRIVER END SNAPPED OFF WHEN TRIED TO TAKE OUT A CROSSLINK SCREW. DRIVER BROKE AND NO FRAGMENTS LEFT IN THE PATIENT'S BODY. THERE WAS DELAY IN OVERALL PROCEDURE TIME FOR 15 SECONDS. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. NO TREATMENT OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT. PATIENT IS ALIVE AND NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12311682 ↗
• MalfunctionJul 6, 2021Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A FIELD CONTACT REGARDING A PATIENT WITH A PRE-OPERATIVE DIAGNOSIS OF LCS, UNDERGOING A REVISION SURGERY. IT WAS REPORTED THAT TLIF WAS PERFORMED ON L5/S1 ON (B)(6) 2020, BUT OB OCCURRED ON THE LEFT S1 SCREW AND NEUROLOGICAL SYMPTOMS OCCURRED. THE LEFT S1 SCREW INSERTED BY THE PES METHOD DEVIATED TO LATERAL. THE SCREW WAS REMOVED, THE DIRECTION WAS CHANGED, AND THE SCREW WAS INSERTED AGAIN. THE CROSSLINK SET SCREW STRIPPED. AN ATTEMPT WAS MADE TO REMOVE IT, BUT THE SET SCREW ON ONE SIDE STRIPPED AND COULD NOT BE REMOVED. THEREFORE, THE ROD WAS REMOVED TOGETHER. NO FORCE WAS APPLIED ON IT, THE SET SCREW WAS STRIPPED FROM THE BEGINNING. INITIAL REPORTER INFORMATION CANNOT BE PROVIDED DUE TO THE RESTRICTION BY THE PRIVACY REGULATION. MDT PRODUCTS USED IN INITIAL SURGERY: SOLERA55/60 ELEVATE PROLOCK DEVICE STATUS REASON : EXPLANTED-COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12120075 ↗
• MalfunctionMay 12, 2021Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT SPINAL THERAPY FOR PAIN DUE TO BROKEN ROD. IT WAS REPORTED THAT REVISION WAS DONE DUE TO ROD BREAKAGE BETWEEN LEFT S1 / S2 AND RIGHT L5 / S. WHEN IT WAS ATTEMPTED TO REMOVE THE PROLOCK THAT WAS ORIGINALLY INSERTED, ONE OF THE FOUR ROD SET SCREWS OF THE TWO PROLOCK STRIPPED AND COULD NOT BE REMOVED. THE CROSSLINK WAS DESTROYED WITH A METAL CUTTER AND REMOVED. DURING REOPERATION, WHEN REMOVING THE SET SCREW OF THE IMPLANTED PROLOCK CROSSLINK, SET SCREW STRIPPED. ORIGINALLY, CROSSLINK WAS PLACED AT L4 / 5 AND L2 / 3. TO REMOVE THE CROSSLINK PLACED AT L4 / 5, AN EGG HANDLE WAS ATTACHED TO THE REMOVAL DRIVER, THE SET SCREW ON THE LEFTSIDE WAS LOOSENED, AND WHEN ATTEMPTED TO LOOSEN THE SET SCREW ON THE RIGHT SIDE, IT STRIPPED. BEFORE LOOSENING THE RIGHT SET SCREW, THE PHYSICIAN SAID THAT T TYPE IS BETTER, SO THE EVENT HAPPENED WHEN CHANGED THE HANDLE TO A MODULAR FIX HANDLE AND ATTACHED IT TO T TYPE. IT HAD BEEN TRIED SEVERAL TIMES, BUT THE SET SCREW ALSO STRIPPED AND COULDN'T BE REMOVED, SO THE IMP WAS DESTROYED WITH A METAL CUTTER AND REMOVED, BUT IT TOOK MORE THAN 30 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11811954 ↗
• MalfunctionSep 4, 2020Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A FIELD CONTACT REGARDING A PRODUCT USED IN SPINAL THERAPY. IT WAS REPORTED THAT, AT THE TIME OF REMOVING CROSS LINK, THE TIP OF THE DRIVER OF THE REMOVAL KIT BROKE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. ALL THE IMPLANT PRODUCTS WERE REMOVED, NO FRAGMENT OF DRIVER TIP REMAINED IN THE BODY. THE PRODUCT WAS ATTEMPTED TO BE REMOVED AS THE BONE UNION WAS ACHIEVED. THE SALES REP ONLY ATTENDED WHEN DIVIDING THE INSTRUMENT, AND HE/SHE ATTENDED ANOTHER OPERATION IN A DIFFERENT OPERATION ROOM. LATER THE SALES REP HEARD ABOUT THE DAMAGE AFTER THE DISTRIBUTOR FINISHED CLEANING UP. THE PRODUCT WILL BE RETURNED AND WILL BE REPLACED. IT WAS REPORTED THAT LOT NUMBER AND LEVELS IMPLANTED ARE UNKNOWN. TYPE OF INITIAL SURGERY: LUMBAR POSTERIOR FUSION.

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

  MAUDE report 10493077 ↗
• MalfunctionApr 4, 2018Break; Break

  IT WAS REPORTED THAT, INTRA-OP, THE TIP OF THE REMOVAL DRIVER BROKE. BROKEN PIECE WAS RETRIEVED FROM THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7395054 ↗
• MalfunctionJan 24, 2018Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A SURGERY DUE TO COMPRESSION FRACTURE AT L3. INTRA-OP, THE DRIVER WAS REPORTED TO BE RELATED TO STRIPPING OF SET SCREW.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7214583 ↗