EXPEDIUM 279726500Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 10705034199528), received between Nov 7, 2017 and Jul 29, 2026 — classified as 12 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Break” (25 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 44 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50073013 ↗
• MalfunctionMay 20, 2026Device-Device Incompatibility

  IT WAS REPORTED WHILE CEMENTING THE TRIALTIS SCREWS A MALFUNCTION IN APPLYING THE CEMENT OCCURRED AND IT PUSHED BACK BETWEEN NEEDLE AND CANNULA. UNKNOWN SURGICAL DELAY. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25232433 ↗
• MalfunctionMar 19, 2026Break

  IT WAS REPORTED THAT DURING A POSTERIOR LUMBAR SPINAL FUSION SURGERY USING VIPER PRIME FS, THE TIP OF THE CANNULA BROKE AND REMAINED INSIDE THE SCREW. TWO CANNULAS BROKE: ONE WAS REMOVED ALONG WITH THE SCREW BEFORE CEMENT INJECTION, WHILE THE OTHER, BROKEN AFTER CEMENT INJECTION, WAS RETAINED. THE SURGERY WAS COMPLETED WITH A SURGICAL DELAY OF APPROXIMATELY 30 MINUTES. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 24637640 ↗
• MalfunctionMar 13, 2026Break

  IT WAS REPORTED THAT DURING A POSTERIOR LUMBAR SPINAL FUSION SURGERY USING VIPER PRIME FS, THE TIP OF THE CANNULA BROKE AND REMAINED INSIDE THE SCREW. TWO CANNULAS BROKE: ONE WAS REMOVED ALONG WITH THE SCREW BEFORE CEMENT INJECTION, WHILE THE OTHER, BROKEN AFTER CEMENT INJECTION, WAS RETAINED. THE SURGERY WAS COMPLETED WITH A SURGICAL DELAY OF APPROXIMATELY 30 MINUTES. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 24593707 ↗
• MalfunctionMay 23, 2025Break; Break

  IT WAS REPORTED THAT WHILE INSERTING THE CEMENT INTO THE FIRST SCREW, THE BACK PART OF THE SYRINGE WITH THE PISTON CAME OFF. AS A RESULT, THE CANNULA WAS ALSO DAMAGED BECAUSE THE CEMENT INSIDE HARDENED. IT WAS NOTED THAT ONCE THEY STARTED SCREWING, AFTER THE FIRST TURN, THE SYRINGE COLLAR, COLLAPSED AND THE LIQUID CONTAINED WITHIN IT CAME OUT. THE INTERNAL GEAR (THE PRESSURE GEAR) BROKE. A SECOND SET WAS OPENED INSTEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22078969 ↗
• MalfunctionMay 19, 2025Break; Break

  IT WAS REPORTED THAT THE CEMENT CANNULA BROKE DURING CEMENTATION. NO FRAGMENTS WERE GENERATED. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22045727 ↗
• InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT HAD BEEN IMPLANTED WITH THE TRIALTIS THORACOLOUMBAR SYSTEM AND DEVELOPED AN INFECTION. THE SURGEON STATED HE IS NEW TO USING TRIALTIS AND HE TYPICALLY DOES NOT SEE INFECTIONS; HE IS CONCERNED THE INFECTIONS MAY BE RELATED TO THE IMPLANTS AND INSTRUMENTATION. IN ADDITION TO IMPLANTING TRIALTIS, CONFIDENCE BONE CEMENT WAS USED.

  Patient problems: Unspecified Infection

  MAUDE report 21041044 ↗
• InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT SPINAL FUSION ON (B)(6) 2024. OVER THE FOLLOWING WEEKEND, THE PATIENT PRESENTED WITH AN INFECTION. PATIENT HAD BEEN IMPLANTED WITH TRIALTIS THORACOLUMBAR SYSTEM. IN ADDITION TO IMPLANTING TRIALTIS, THE SURGEON USED CONFIDENCE BONE CEMENT.

  Patient problems: Unspecified Infection

  MAUDE report 21038270 ↗
• InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT HAD BEEN IMPLANTED WITH THE TRIALTIS THORACOLOUMBAR SYSTEM AND DEVELOPED AN INFECTION. THE SURGEON STATED HE IS NEW TO USING TRIALTIS AND HE TYPICALLY DOES NOT SEE INFECTIONS; HE IS CONCERNED THE INFECTIONS MAY BE RELATED TO THE IMPLANTS AND INSTRUMENTATION. IN ADDITION TO IMPLANTING TRIALTIS, CONFIDENCE BONE CEMENT WAS USED.

  Patient problems: Unspecified Infection

  MAUDE report 21036807 ↗
• InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT HAD BEEN IMPLANTED WITH THE TRIALTIS THORACOLOUMBAR SYSTEM AND DEVELOPED AN INFECTION. THE SURGEON STATED HE IS NEW TO USING TRIALTIS AND HE TYPICALLY DOES NOT SEE INFECTIONS; HE IS CONCERNED THE INFECTIONS MAY BE RELATED TO THE IMPLANTS AND INSTRUMENTATION. IN ADDITION TO IMPLANTING TRIALTIS, CONFIDENCE BONE CEMENT WAS USED.

  Patient problems: Unspecified Infection

  MAUDE report 21036786 ↗
• InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT HAD BEEN IMPLANTED WITH THE TRIALTIS THORACOLUMBAR SYSTEM AND DEVELOPED AN INFECTION. THE SURGEON STATED HE IS NEW TO USING TRIALTIS AND HE TYPICALLY DOES NOT SEE INFECTIONS; HE IS CONCERNED THE INFECTIONS MAY BE RELATED TO THE IMPLANTS AND INSTRUMENTATION. IN ADDITION TO IMPLANTING TRIALTIS, CONFIDENCE BONE CEMENT WAS USED.

  Patient problems: Unspecified Infection

  MAUDE report 21036458 ↗
• InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT SPINAL FUSION ON (B)(6) 2024. OVER THE FOLLOWING WEEKEND, THE PATIENT PRESENTED WITH AN INFECTION. PATIENT HAD BEEN IMPLANTED WITH TRIALTIS THORACOLUMBAR SYSTEM. IN ADDITION TO IMPLANTING TRIALTIS, THE SURGEON USED CONFIDENCE BONE CEMENT.

  Patient problems: Unspecified Infection

  MAUDE report 21035830 ↗
• InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT HAD BEEN IMPLANTED WITH THE TRIALTIS THORACOLOUMBAR SYSTEM AND DEVELOPED AN INFECTION. THE ORIGINAL PROCEDURE OCCURRED ON (B)(6) 2024. THE SURGEON INCIDENT HE IS NEW TO USING TRIALTIS AND STATES HE TYPICALLY DOES NOT SEE INFECTIONS; HE IS CONCERNED THE INFECTIONS MAY BE RELATED TO THE IMPLANTS AND INSTRUMENTATION. IN ADDITION TO IMPLANTING TRIALTIS, CONFIDENCE BONE CEMENT WAS USED.

  Patient problems: Unspecified Infection

  MAUDE report 21035788 ↗
• InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT HAD BEEN IMPLANTED WITH THE TRIALTIS THORACOLUMBAR SYSTEM AND DEVELOPED AN INFECTION. THE ORIGINAL PROCEDURE OCCURRED ON (B)(6) 2024. THE SURGEON INCIDENT HE IS NEW TO USING TRIALTIS AND STATES HE TYPICALLY DOES NOT SEE INFECTIONS; HE IS CONCERNED THE INFECTIONS MAY BE RELATED TO THE IMPLANTS AND INSTRUMENTATION. IN ADDITION TO IMPLANTING TRIALTIS, CONFIDENCE BONE CEMENT WAS USED.

  Patient problems: Unspecified Infection

  MAUDE report 21035536 ↗
• MalfunctionNov 15, 2024Break; Break

  IT WAS REPORTED THAT THIS WAS A PERCUTANEOUS VERTEBROPLASTY (LUMBAR) FOR VERTEBRAL FRACTURE ON (B)(6) 2024. DURING SURGERY, THE STENT DID NOT DILATE, RESULTING IN PROLONGED SURGERY TIME. AND BECAUSE THE CEMENT HAS HARDENED, A NEW SET HAD TO BE USED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20695450 ↗
• MalfunctionJul 17, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, DURING A POSTERIOR FUSION WITH A FENESTRATED SCREW, WHEN USING THE SYRINGE IN THE SYRINGE KIT AND THE CONFIDENCE ADAPTER, THE SURGEON TRIED TO ATTACH IT TO THE OPEN CANNULA, BUT IT DID NOT FIT PROPERLY. A NEW OPEN CANNULA WAS OPENED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THE PATIENT WAS REPORTED AS STABLE. THIS REPORT INVOLVES ONE (1) EXPEDIUM SPINE SYSTEM FENESTRATED SCREW OPEN CANNULA 16G X 160MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19760719 ↗
• MalfunctionSep 21, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A PSF FOR A CHANCE FRACTURE ON (B)(6) 2023. AFTER INJECTING CEMENT THROUGH THE OPEN CANNULA, THE SURGEON REMOVED THE OPEN CANNULA AND FOUND THAT ABOUT 10 CM FROM THE TIP OF IT, THE PART WHERE THE THICKNESS CHANGES, WAS BROKE OFF. IT WAS HIGHLY POSSIBLY THAT THE OPEN CANNULA BROKE OFF WHEN IT WAS REMOVED BECAUSE THERE HAD BEEN NO PROBLEMS WITH THE OPEN CANNULA DURING CEMENT PREPARATION. INJECTION OF THE REMAINING CEMENT WAS COMPLETED USING ANOTHER CANNULA. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. PATIENT STATUS/OUTCOME: STABLE. THERE WERE NO FRAGMENTS OF THE DAMAGED OPEN CANNULA LEFT IN THE PATIENT¿S BODY. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN BIOMATERIAL - CEMENT (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN) THIS REPORT IS FOR ONE (1) FEN OPEN CANNULA STRL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17789365 ↗
• MalfunctionSep 13, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE OPEN CANNULA WAS FOUND TO BE BROKEN OFF BY BEING BURIED IN OTHER DEVICES. NO FRAGMENTS WERE RETAINED IN THE PATIENT¿S BODY, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. IT WAS FURTHER REPORTED THAT A TOTAL OF TWO CANNULAS WERE BROKEN. ONE WAS FOUND TO BE BROKEN OFF DURING SURGERY, AND ANOTHER WAS BROKEN INTENTIONALLY AFTER SURGERY FOR CHECKING. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM FENESTRATED SCREW OPEN CANNULA 16G X 160MM. THIS REPORT IS RELATED TO (B)(4), WHICH REPORTS THE CANNULA THAT WAS BROKEN DURING SURGERY. THIS REPORT CAPTURES THE CANNULA BROKEN INTENTIONALLY AFTER SURGERY. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17736587 ↗
• MalfunctionAug 22, 2023Break; Entrapment of Device; Break; Entrapment of Device

  THIS REPORT INVOLVES ONE UNK GUIDE/SLEEVE/AIMING. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17595399 ↗
• MalfunctionAug 14, 2023Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED DURING A SPINAL FUSION TO TREAT THE VERTEBRAL BODY FRACTURE ON (B)(6), 2023, WHEN A NURSE OPENED THE OPEN CANNULA, THE TIP PART OF THE OPEN CANNULA DROPPED OFF AND FOUND TO BE BROKEN. THE CEMENT INJECTION COULD NOT BE PERFORMED BECAUSE THE OPEN CANNULA IN QUESTION WAS THE LAST ONE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH SIXTY (60) MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) FEN OPEN CANNULA STRL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17543183 ↗
• MalfunctionJun 5, 2023Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT DURING A POSTERIOR FUSION (T10) FOR A COMPRESSION FRACTURE ON (B)(6) 2023, THE OPEN CANNULA COULD NOT BE PLACED IN ONE OF THE FOUR SCREWS AFTER ALIGNMENT DEVICES WERE ATTACHED. DESPITE REPLACING AN ALIGNMENT DEVICE AND REPLACING THE OPEN CANNULA SEVERAL TIMES, THE OPEN CANNULA COULD NOT BE PLACED. CEMENT WAS UNABLE TO BE APPLIED TO THE PEDICLE WHERE THE CANNULA WASN¿T ABLE TO BE INSERTED. DURING THE TRIALS, THE OPEN CANNULA BROKE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM FENESTRATED SCREW OPEN CANNULA 16G X 160MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17059836 ↗
• MalfunctionJun 1, 2023Material Deformation; Material Deformation

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CHINA AS FOLLOWS: IT WAS REPORTED THAT UPON OPENING THE PACKAGING, THE NEEDLE IS CROOKED (AS THE PHOTO SHOW. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) FEN OPEN CANNULA STRL THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17041012 ↗
• MalfunctionApr 17, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, DURING A PERCUTANEOUS POSTERIOR SPINAL FUSION (TH12) FOR BURST FRACTURE THE CEMENT AND FENESTRATED SCREWS WERE USED FOR THE TREATMENT. CEMENT WAS PLANNED TO USE IN 4 SPOTS. IN THE PREOPERATIVE MEETING, IT WAS DECIDED TO INJECT CEMENT INTO 1 SPOT AT A TIME, SO THE OPEN CANNULA IN QUESTION WAS PREPARED IN THE SURGICAL FIELD AT FIRST. TO PREVENT CEMENT LEAKAGE, THE SURGEON CAREFULLY JUDGED THE VISCOSITY OF THE CEMENT, WHICH DID NOT EASILY REACH THE VISCOSITY SPECIFIED BY THE SOCIETY, AND CEMENT INJECTING WAS STARTED AFTER FIFTEEN(15) MINUTES AND THIRYT(30) SECONDS AFTER MIXING. AT THE STAGE OF INJECTING CEMENT INTO THE 1ST SPOT, A SYRINGE WAS VERY STIFF TO PUSH. AT THE 2ND STAGE OF INJECTING CEMENT INTO THE SPOT, THE SYRINGE COULD NOT BE PUSHED AT ALL. THE CEMENT FILLED IN ANOTHER SYRINGE WAS STILL SOFT TO USE WHEN CHECKED. THEREFORE, THE SURGEON USED ANOTHER NEW OPEN CANNULA AND TRIED TO PUSH THE SYRINGE THAT HAD BEEN USED BEFORE, BUT THE SYRINGE COULD NOT BE PUSHED. AT THIS POINT, TWENTY-ONE(21) MINUTES HAD PASSED FROM THE MIXING OF THE CEMENT, AND THE SALES REP SUGGESTED THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16752629 ↗
• InjuryMar 17, 2023Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, DURING A PLIF (RIGHT L5) FOR THE SPINAL STENOSIS WHEN THE OPEN CANNULA WAS ATTACHED AFTER ATTACHING SCREW¿S ALIGNMENT DEVICE, THE TIP OF THE OPEN CANNULA WAS BROKEN. AT FIRST, THE OTHER OPEN CANNULA WAS PUSHED WITHOUT NOTICING. LATER IT WAS DIFFICULT TO REMOVE THE BROKEN TIP AND THE SURGEON DECIDED TO LEAVE THE IT INSIDE THE BODY. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. ACCORDING TO THE SURGEON, IT WAS OPEN SURGICAL TECHNIQUE AND THE ROTATION OF THE VERTEBRAL BODY WAS STRONG. THE ALIGNMENT DEVICE HAD TO BE TILTED CONSIDERABLY AND THERE WAS EXCESSIVE TENSION. AT THAT TIME, THE TIP OF THE OPEN CANNULAR WAS BENT AND BROKEN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) EXPEDIUM SPINE SYSTEM FENESTRATED SCREW OPEN CANNULA 16G X 160MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 16564561 ↗
• MalfunctionMar 9, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS AN UNKNOWN SURGERY PERFORMED ON (B)(6) 2023. WHEN THE SURGEON OPENED THE PACKAGE OF THE OPEN CANNULA, THE TIP OF THE OPEN CANNULA WAS BROKEN. A SPARE OPEN CANNULA WAS USED FOR SURGERY. IT DID NOT AFFECT THE OPERATION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. PATIENT STATUS/ OUTCOME: STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) FEN OPEN CANNULA STRL THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16512343 ↗