N/A 5485901Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00643169063969), received between May 8, 2024 and Sep 20, 2026 — classified as 27 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (10 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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 20, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50834767 ↗
• MalfunctionJul 10, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25774722 ↗
• MalfunctionMay 29, 2026Break

  INFORMATION WAS RECEIVED FROM MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT, THE INSTRUMENTS 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 25331009 ↗
• MalfunctionApr 2, 2026Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR DIRECT LATERAL INTERBODY FUSION (DLIF). IT WAS REPORTED THAT THE EXTENDER WAS FOUND TO BE BENT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24762055 ↗
• MalfunctionFeb 25, 2026Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT IDENTIFIED DURING AN EVENT. IT WAS REPORTED THAT EXTENDER WAS BENT. NO PATIENT WAS INVOLVED IN THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24441619 ↗
• MalfunctionSep 8, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR FIXAT ION. IT WAS REPORTED THAT THE SCREW HEAD PART DOES NOT HOLD. 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 22991920 ↗
• MalfunctionAug 12, 2025Material Twisted/Bent; Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED PRIOR TO USE. IT WAS REPORTED THAT TIPS OF THE REDUCER ARE BENT AND NOT PROPERLY SITTING ON TOP OF TULIP HEAD TO PROVIDENCE APPROPRIATE ROD REDUCTION. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22784623 ↗
• MalfunctionMar 20, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING EXTENDERS. IT WAS REPORTED THAT EXTENDERS WERE GETTING CAUGHT UP ON INNERS. THERE WAS NO PATIENT INVOLVEMENT AS THE EVENT OCCURRED AT BACK TABLE. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21652641 ↗
• MalfunctionMar 20, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING EXTENDERS. IT WAS REPORTED THAT EXTENDERS WERE GETTING CAUGHT UP ON INNERS. THERE WAS NO PATIENT INVOLVEMENT AS THE EVENT OCCURRED AT BACK TABLE. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21652619 ↗
• MalfunctionMar 20, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING EXTENDERS. IT WAS REPORTED THAT EXTENDERS WERE GETTING CAUGHT UP ON INNERS. THERE WAS NO PATIENT INVOLVEMENT AS THE EVENT OCCURRED AT BACK TABLE. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21652556 ↗
• MalfunctionMar 20, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING EXTENDERS. IT WAS REPORTED THAT EXTENDERS WERE GETTING CAUGHT UP ON INNERS. THERE WAS NO PATIENT INVOLVEMENT AS THE EVENT OCCURRED AT BACK TABLE. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21652346 ↗
• MalfunctionFeb 18, 2025Degraded; Mechanical Problem; Degraded; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING DECOMPRESSION AND INSTRUMENTED FUSION SPINAL THERAPY FOR SCOLIOSIS. LEVELS IMPLANTED WAS T4-PELVIS. IT WAS REPORTED THAT DURING A PROCEDURE THERE WAS AN ISSUE WITH THE DEVICES THAT ONE OF THE TABS ON EACH EXTENDER HAD WORN DOWN TO THE POINT OF NOT HOLDING ONTO THE HEAD OF THE SCREW ADEQUATELY, CAUSING IT TO POP OFF DURING USE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT. NO ADDITIONAL TREATMENT OR SURGERY WAS PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21401567 ↗
• MalfunctionFeb 11, 2025Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE INSTRUMENTS GOT OLD AND 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 21353974 ↗
• MalfunctionJan 10, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT UNDERGOING POSTERIOR SPINAL FUSION FOR CORRECTION OF ADOLESCENT IDIOPATHIC SCOLIOSIS. IT WAS REPORTED THAT THE CLOSED EXTENDER WAS 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 21121814 ↗
• MalfunctionNov 18, 2024Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING PRODUCTS USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE DEVICE HAS IMPROPER FUNCTION. THERE WAS NO PATIENT INVOLVEMENT AND NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20704990 ↗
• MalfunctionNov 14, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR CONGENITAL SCOLIOSIS. IT WAS REPORTED THAT UPON NORMAL USE OF THE SMARTLINK EXTENDER,ONE OF THE POSTS THAT CONNECTS TO THE SCREW HEAD BROKE WHEN ATTEMPTING TO REDUCE THE ROD INTO THE SCREW HEAD. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. 2024-OCT-24_E1 (REP): ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE THERE WAS NO ISSUE WITH THE SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20681738 ↗
• MalfunctionNov 1, 2024Material Twisted/Bent; Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING DECOMPRESSION AND INSTRUMENTED FUSION AT LEVELS IMPLANTED T10-PELVIS. PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE WAS SPINAL STENOSIS. IT WAS REPORTED THAT INSTRUMENT WAS BENT AND WOULD NOT ATTACH PROPERLY TO SCREW. 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 20585982 ↗
• MalfunctionSep 3, 2024Break; Mechanical Problem; Break; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL FUSION. LEVELS IMPLANTED - T10 - L4. IT WAS REPORTED THAT THE EXTENDER WAS BROKEN. THE THREADED REDUCER TUBE WOULD NOT FULLY EXTEND DOWN THE EXTENDER. 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 20124355 ↗
• MalfunctionAug 27, 2024Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A EXTENDER, REDUCER USED FOR ADOLESCENT IDIO PATHIC SCOLIOSIS (AIS) THERAPY. IT WAS REPORTED THAT THE EXTENDER WAS NOT LOCKING IN PLACE AND THE REDUCER WAS COMING OUT OF PLACE FROM THE EXTENDER. THE REDUCER WAS NOT LOCKING PROPERLY ON ITS OWN. PRODUCTS HAD BEEN USED IN PRIOR PROCEDURE/ SURGERY. 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 20074480 ↗
• MalfunctionAug 27, 2024Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE EXTENDER WAS HAVING ISSUES OPENING AND CLOSING. 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 20072967 ↗
• MalfunctionAug 22, 2024Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIA GNOSIS FOR SPINAL STENOSIS. PROCEDURE PERFORMED WAS T10 - S2AI POSTERIOR SPINAL FUSION. IT WAS REPORTED THAT WHILE ATTACHING THE SMARTLINK TO SCREW TULIP THE TIP OF ONE SIDE OF THE TOWER BROKE OFF. THE FRAGMENT WAS RETRIEVED LEAVING NOTHING IN THE PATIENT AND ALTERNATIVE TOWER WAS USED TO COMPLETE SURGERY. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20028491 ↗
• MalfunctionMay 14, 2024Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A CLOSED EXTENDER USED FOR SPINAL THERAPY. IT WAS REPORTED THAT 5 CLOSED TOWERS WERE UNABLE TO BE FULLY REDUCED EITHER BY HAND OR WITH THE REDUCTION DRIVER. ISSUE WAS OBSERVED UPON DELIVERY OF TWO BRAND NEW SETS OF SMARTLINKS. 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 19308816 ↗
• MalfunctionMay 14, 2024Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A CLOSED EXTENDER USED FOR SPINAL THERAPY. IT WAS REPORTED THAT 5 CLOSED TOWERS WERE UNABLE TO BE FULLY REDUCED EITHER BY HAND OR WITH THE REDUCTION DRIVER. ISSUE WAS OBSERVED UPON DELIVERY OF TWO BRAND NEW SETS OF SMARTLINKS. 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 19308813 ↗
• MalfunctionMay 14, 2024Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A CLOSED EXTENDER USED FOR SPINAL THERAPY. IT WAS REPORTED THAT 5 CLOSED TOWERS WERE UNABLE TO BE FULLY REDUCED EITHER BY HAND OR WITH THE REDUCTION DRIVER. ISSUE WAS OBSERVED UPON DELIVERY OF TWO BRAND NEW SETS OF SMARTLINKS. 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 19308803 ↗
• MalfunctionMay 14, 2024Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A CLOSED EXTENDER USED FOR SPINAL THERAPY. IT WAS REPORTED THAT 5 CLOSED TOWERS WERE UNABLE TO BE FULLY REDUCED EITHER BY HAND OR WITH THE REDUCTION DRIVER. ISSUE WAS OBSERVED UPON DELIVERY OF TWO BRAND NEW SETS OF SMARTLINKS. 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 19308782 ↗