N/A 8110535Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00721902738838), received between May 1, 2017 and Mar 17, 2026 — classified as 1 injury, 35 malfunctions.

The most frequently reported specific device problem is “Break” (24 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2026Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT IDENTIFIED DURING AN EVENT. IT WAS REPORTED THAT INSTRUMENTS WERE BROKEN AND PEELING TRAYS. THERE WAS NO PATIENT INVOLVED IN THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24615208 ↗
• MalfunctionMar 17, 2026Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT IDENTIFIED DURING AN EVENT. IT WAS REPORTED THAT INSTRUMENTS WERE BROKEN AND PEELING TRAYS. THERE WAS NO PATIENT INVOLVED IN THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24615204 ↗
• MalfunctionMar 17, 2026Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT IDENTIFIED DURING AN EVENT. IT WAS REPORTED THAT INSTRUMENTS WERE BROKEN AND PEELING TRAYS. THERE WAS NO PATIENT INVOLVED IN THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24615199 ↗
• MalfunctionMar 4, 2026Break; Material Deformation

  EVENT OCCURRED INTRA-OP AND NO PATIENT HARM WAS EVER REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24514160 ↗
• MalfunctionFeb 13, 2026Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REP ORTED THAT, THE INSTRUMENTS WERE BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24332765 ↗
• MalfunctionDec 23, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A USED IN A SPINE SURGERY. IT WAS REPORTED THAT THE DRIVERS WERE BROKEN. THERE WAS NO PATIENT INVOLVED. ADDITIONAL INFORMATION WAS RECEIVED THAT IT OCCURRED INTRA-OP, NO FRAGMENTS WERE LEFT IN PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23885886 ↗
• MalfunctionDec 23, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING DECOMPRESSION AND LUMBAR FUSION SPINAL THERAPY FOR STENOSIS. IT WAS REPORTED THAT DURING THE FINAL TIGHTENING OF THE CENTER LOCK SCREW OF THE CROSSLINK, THE TIP OF THE SHAFT SHEARED APART INTRA -OPERATIVELY. THERE WERE NO FRAGMENTS OF THE INSTRUMENT REMAINED IN THE PATIENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS OCCURRED AS A RESULT OF THIS EVENT AND NO TREATMENT OR ADDITIONAL SURGERY WAS PERFORMED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23874823 ↗
• MalfunctionNov 5, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT. IT WAS REPORTED THAT BREAK OFF HANDLE¿S BLUE RUBBER IS CRACKED, CROSSLINKS DRIVER¿S TIP IS CRACKED/CHIPPED, T-25 OBTURATOR¿S TIP IS WORN DOWN, T-20 DRIVER TIP IS WORN DOWN, RATCHET HANDLES (X2) ARE GETTING STUCK AND WON¿T RATCHET PROPERLY, LOCK SLEEVE DRIVER (X1) HAS A WORN DOWN TIP, LOCK SLEEVE DRIVER (X1) HAS A BROKEN DRIVER TIP AND 4.75 MAS SCREWDRIVER HAS A WORN DOWN TIP. 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 23473400 ↗
• MalfunctionOct 15, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A DRIVER USED ON PATIENT HAVING TLIF L1-2 EXTENSION PROCEDURE THERAPY FOR DEGENERATIVE DISC DISEASE AND ADJACENT LEVEL OSSIFICATION AT L1-2 IT WAS REPORTED THAT THE DRIVER USED FOR FINAL TIGHTENING OF THE GOLD BREAKOFF SCREWS ON THE X-10 CROSSLINK BROKE, WITH THE TIP OF THE DRIVER COMPLETELY BREAKING OFF. SURGEON NEVER GOT THE BREAKOFF PORTION OF THE CROSSLINK OFF, AND REMOVAL OF THE CROSSLINK WAS REQUIRED. AS A RESULT, THE SURGICAL TEAM WAS UNABLE TO PROCEED WITH PLACEMENT OF THE CROSSLINK FOR STABILIZATION OF THE CONSTRUCT. THIS WAS NOT THE FIRST TIME THIS DRIVER HAD BEEN USED. THERE WAS NO SIGNIFICANT DELAY OF THE PROCEDURE. 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 23288580 ↗
• MalfunctionJul 24, 2025Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT, THE INSTRUMENT'S TORQUE WAS FAILED. THERE WAS NO PATIENT INVOLVEMENT REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22584820 ↗
• MalfunctionMar 26, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING PLF T10-S2, PLI F/TLIF L2-S1 PROCEDURE. IT WAS REPORTED THAT DURING THE FINAL TIGHTENING OF THE X10 CROSSLINKS, THE TORQUE DRIVER BROKE AT THE DISTAL TIP. NO FRAGMENTS WERE BROKEN OFF AND NO FOREIGN BODIES WERE LEFT IN THE PATIENT. 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 21697827 ↗
• MalfunctionMar 14, 2025Fracture; Fracture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING LUMBAR FUSION AT LEVELS L3-S1 FOR DEGENERATIVE DISC DISEASE. IT WAS REPORTED THAT WHEN THE SURGEON USED THE TORQUE LIMITING DRIVER TO TIGHTEN DOWN THE GOLD SET SCREWS HE MADE THE COMMENT THAT THE DRIVER WASN'T CATCHING THE HEX PORTION OF THE SCREW. IT KEEPS SKIPPING AROUND THE SCREW. UPON LOOKING AT THE DRIVER AFTER THE CASE, THERE APPEARS TO BE A STRESS FRACTURE IN THE DISTAL TIP OF THE DRIVER. 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 21603279 ↗
• MalfunctionMar 12, 2025Break; Break

  INFORMATION WAS RECEIVED FROM THE USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT DRIVER BROKE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE TIP OF THE DRIVER THE BROKE. THEREFORE, WHEN YOU TRY AND TIGHTEN THE SCREW IT DISPLAYS OPEN AND DOESN¿T PROPERLY GRAB THE SCREW. THIS ITEM HAS BEEN USED MANY TIMES BEFORE THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21580877 ↗
• MalfunctionFeb 18, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING OPEN THORACIC F USION FOR ABSCESS. IT WAS REPORTED THAT THE DEVICE HAS BROKEN. 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 21393817 ↗
• MalfunctionFeb 12, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR THORA CIC FUSION WITH CROSSLINK FOR THORACIC SPINE FRACTURE. IT WAS REPORTED THAT THE DRIVER BROKE. 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 21361532 ↗
• MalfunctionFeb 11, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING FEW INSTRUMENTS USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKEN. PRODUCTS WILL BE RETURNED. THERE WAS NO PATIENT INVOLVED IN THE EVENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21353852 ↗
• MalfunctionFeb 3, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR OPEN TLIF PROC EDURE. LEVELS IMPLANTED: L4-S1 IT WAS REPORTED THAT THE TIP SHEARED OFF. A BACK UP DRIVER WAS USED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. THERE WERE NO PATIENT SYMPTOMS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21289966 ↗
• MalfunctionOct 10, 2024Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT, INSTRUMENTS EITHER HAVE A BROKEN RATCHET HANDLE OR THE DRIVER IS STRIPPED. THERE WAS NO PATIENT INVOLVEMENT REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20415111 ↗
• MalfunctionSep 18, 2024Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REP ORTED THAT THE DEVICES WERE BROKEN. 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 20244388 ↗
• MalfunctionJul 1, 2024Break; Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED POST-OP. IT WAS REPORTED THAT WHILE REPROCESSING TRAYS REP NOTICED A CRACK IN THE END OF THE INSTRUMENT. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19642306 ↗
• MalfunctionJul 1, 2024Fracture; Fracture

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REP ORTED THAT THE WORKING HEX TIP IS FRACTURED AND CANNOT TIGHTEN THE NUTS. 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 19641442 ↗
• MalfunctionApr 5, 2023Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A CROSSLINK AND DRIVER USED IN T11/T12 DECOMPRESSION AND POSTEROLATERAL FUSION FOR STENOSIS. LEVELS IMPLANTED: T11 AND T12 IT WAS REPORTED THAT THE CROSSLINK WAS ATTACHED TO THE RODS AND THE GOLD SCREWS WERE TIGHTENED. THE CENTRAL SCREW ON THE CROSSLINK WOULDN¿T TIGHTEN AND TORQUE OFF AS NORMAL. THE SURGEON WAS CONCERNED THAT THE DRIVER WASN¿T WORKING PROPERLY AND TURNING THE SCREW. HE THOUGHT IT WAS POSSIBLY STRIPPING/ MAKING INDENTATIONS ON THE SCREW HEAD. THE CROSSLINK WAS REMOVED AND REPLACED WITH A NEW CROSSLINK. THE DRIVER WAS USED ON THE PATIENT DURING THE SURGERY. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16680834 ↗
• MalfunctionNov 9, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH POSTERIOR LUMBAR INTERBODY FUSION THERAPY. LEVELS IMPLANTED 2/3. IT WAS REPORTED THAT THE TIP OF THE SETSCREW DRIVER BROKE WHEN TORQUING OFF THE SECOND BREAK OFF SET SCREW. THERE WAS NO FRAGMENT LEFT IN THE PATIENT. THE PATIENT CAME IN CONTACT WITH REPORTED PRODUCT WHILE TORQUING OFF THE SET SCREWS. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12776494 ↗
• MalfunctionAug 23, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING T10-PELVIS LUM BAR/PELVIC FUSION REVISION DUE TO UNKNOWN INDICATION. IT WAS REPORTED THAT TIP OF DRIVER BROKE WHILE TIGHTENING CROSSLINK. TIGHTENING COMPLETED USING ANOTHER DRIVER. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12352305 ↗
• MalfunctionFeb 15, 2021Naturally Worn; Naturally Worn

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH LUMBAR FIXATION AND FUSION DUE TO LUMBAR DEGENERATION. IT WAS REPORTED THAT THE CROSSLINK SCREW CAP WAS FOUND BROKEN DURING X-RAY BEFORE THE PATIENT WAS DISCHARGED FROM THE HOSPITAL, AND A PART OF THE SCREW CAP FELL ON THE EPIDURAL OF THE LUMBAR SPINE. THE NUT OF THE X10 CROSSLINK WAS ABNORMALLY BROKEN AND BROKE IN THE PATIENT'S BODY AFTER THE SURGERY. CROSSLINK REMAINS IMPLANTED. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11326619 ↗