NA 698337540Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705034377377), received between Jun 19, 2018 and Sep 20, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 20, 2023Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2023, DURING LOAN KIT INSPECTION IT WAS NOTICED THAT THE TIP OF THE TIGHTENER HAS WORN OUT. THIS REPORT INVOLVES ONE (1) MODIFIED INSTRUMENT INNIE TIGHTENER, LONG X25. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17783189 ↗
• MalfunctionJan 10, 2023Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, THAT THE DR WAS PERFORMING A L3-5 POSTERIOR SPINAL FUSION AND WHEN HE WAS DOING THE FINAL TORQUE ON THE SET SCREWS USING THE LONG MOD X25 FINAL TIGHTENER, THE TIP OF THE DRIVER WAS NOTED TO BE BURRED AND UNABLE TO BE USED. THIS DRIVER WAS PUT TO THE SIDE AND A SHORT X25 DRIVER WAS USED INSTEAD. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS/ OUTCOME / CONSEQUENCES :NO. THIS REPORT IS FOR ONE (1) MOD X25 INNIE TIGHTENER LONG. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16131154 ↗
• MalfunctionAug 16, 2022Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE SURGEON HAD BOOKED A L4-S1 POSTERIOR SPINAL FUSION USING EXPEDIUM AND A LOAN SET WAS SENT. WHILE THE SCRUB NURSE WAS SETTING UP THE EXPEDIUM SET PRIOR TO THE CASE BEGINNING, IT WAS NOTICED THAT THE TIP OF THE LONG X25 FINAL TIGHTENER WAS BURRED. THIS ITEM WAS PUT TO THE SIDE OF THE NURSES STERILE TABLE AND NOT USED DURING THE CASE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE (1) MODIFIED INSTRUMENT INNIE TIGHTENER, LONG X25. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15233470 ↗
• MalfunctionJul 20, 2022Material Deformation; Material Deformation

  DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, WHILE THE SCRUB NURSE WAS SETTING UP THE INSTRUMENTS FOR A LOAN EXPEDIUM SET, IT WAS NOTICED THAT THE TIP OF THE LONG X25 DRIVER WAS BURRED AT THE TIP. THERE WAS NO PATIENT INVOLVEMENT, NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A MODIFIED INSTRUMENT INNIE TIGHTENER, LONG X25. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15067922 ↗
• MalfunctionJun 19, 2018Material Fragmentation; Material Fragmentation

  SELECTIVE THORACIC FUSION. DR (B)(6) WAS PERFORMING AN AIS SPINAL FUSION AND WENT TO USE THE X25 FINAL TIGHTENER, EXTRA LONG SHAFT,TO TORQUE THE SET SCREW. HE SAID THAT THE INSTRUMENT WAS BURRED AND DID NOT WANT TO USE IT, IT NEEDED TO BE REPLACED. THIS SRI INSTRUMENT HAS BEEN SPECIFICALLY MADE TO ENABLE DR (B)(6) TO PERFORM SPINAL CORRECTION MOVEMENTS, ACHIEVE SEGMENTAL FIXATION AND FINAL TIGHTENING, AT THE SAME TIME. THERE IS ONLY ONE OF THESE INSTRUMENTS ON THE SET. HE HAD TO USE THE REGULAR FINAL TIGHTENER(REGULAR X25 SHAFT). THERE WAS A MINIMAL DELAY TO THE SURGERY. NO AE TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 7614519 ↗