EXPEDIUM 179702000SRecalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 10705034265063), received between Jan 18, 2019 and Feb 18, 2026 — classified as 31 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (14 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 52 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 18, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE VCFFX SCREW COULD NOT BE LOCKED WITH SET SCREW. THERE WAS A THIRTY (30) MINUTE DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24377898 ↗
• MalfunctionApr 25, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A SPINAL FUSION SURGERY, THE LOOKING SET SCREW BECAME STRIPPED AND COULD NOT BE USED. IT WAS REPLACED WITH A NEW ONE, WITH NO CONSEQUENCES FOR THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21909336 ↗
• InjuryMay 22, 2024Device Slipped; Device Slipped

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT HAD A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) AT L1-2 AND EXTENSION OF PSIF TO L1-L5 ON (B)(6) 2023. HE SUBSEQUENTLY HAD LOWER BACK PAIN AND IMAGING IDENTIFIED LOOSENING OF HARDWARE SEVERAL WEEKS LATER. HE ELECTED TO HAVE A SURGICAL REVISION OF THE SET SCREW AT L1. THE SURGEON EXPLAINED THAT DURING SURGERY, IT WAS NOTED THAT THE SET SCREW WAS LOOSE WHERE IT CONNECTED WITH THE ROD. TWO SET SCREWS WERE NOT TIGHTLY CONNECTED TO THE HEAD OF THE PEDICLE SCREW. THIS REPORT IS FOR A SET SCREW. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 19370958 ↗
• InjuryMay 17, 2024Device Slipped; Device Slipped

  ON (B)(6) 2024, AN EXP 5.5 REVISION SURGERY TOOK PLACE AT THE HOSPITAL. DURING THIS SURGERY IT WAS DISCOVERED THAT ALL EIGHT EXP INNIES WERE LOOSE. THE REVISION SURGERY TOOK PLACE BECAUSE THE PATIENT HAD AN INFECTION AND THE SCREWS BECAME LOOSE. SURGERY WAS NOT DELAYED THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FRAGMENTS WERE GENERATED. THIS REPORT IS FOR A SINGLE-INNER SETSCREW THIS IS REPORT 1 OF 10 FOR (B)(4). (B)(4) IS RELATED TO THIS (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 19341190 ↗
• InjuryMay 16, 2024Device Slipped; Device Slipped

  ON (B)(6) 2024, AN EXP 5.5 REVISION SURGERY TOOK PLACE AT THE HOSPITAL. DURING THIS SURGERY IT WAS DISCOVERED THAT ALL EIGHT EPININE WERE LOOSE. THE REVISION SURGERY TOOK PLACE BECAUSE THE PATIENT HAD AN INFECTION AND THE SCREWS BECAME LOOSE. SURGERY WAS NOT DELAYED THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FRAGMENTS WERE GENERATED. THIS REPORT INVOLVES ONE (1) SINGLE-INNER SETSCREW THIS IS REPORT 8 OF 10 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 19336591 ↗
• InjuryMay 16, 2024Device Slipped; Device Slipped

  ON (B)(6) 2024, AN EXP 5.5 REVISION SURGERY TOOK PLACE AT THE HOSPITAL. DURING THIS SURGERY IT WAS DISCOVERED THAT ALL EIGHT EXP INNIES WERE LOOSE. THE REVISION SURGERY TOOK PLACE BECAUSE THE PATIENT HAD AN INFECTION AND THE SCREWS BECAME LOOSE. SURGERY WAS NOT DELAYED THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FRAGMENTS WERE GENERATED. THIS REPORT INVOLVES ONE (1) SINGLE-INNER SETSCREW. THIS IS REPORT 7 OF 10 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 19336519 ↗
• InjuryMay 16, 2024Device Slipped; Device Slipped

  ON (B)(6) 2024, AN EXP 5.5 REVISION SURGERY TOOK PLACE AT THE HOSPITAL. DURING THIS SURGERY IT WAS DISCOVERED THAT ALL EIGHT EXP INNIES WERE LOOSE. THE REVISION SURGERY TOOK PLACE BECAUSE THE PATIENT HAD AN INFECTION AND THE SCREWS BECAME LOOSE. SURGERY WAS NOT DELAYED THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FRAGMENTS WERE GENERATED. THIS REPORT INVOLVES ONE (1) SINGLE-INNER SETSCREW. THIS IS REPORT 6 OF 10 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 19336177 ↗
• InjuryMay 16, 2024Device Slipped; Device Slipped

  ON (B)(6) 2024, AN EXP 5.5 REVISION SURGERY TOOK PLACE AT THE HOSPITAL. DURING THIS SURGERY IT WAS DISCOVERED THAT ALL EIGHT EXP INNIES WERE LOOSE. THE REVISION SURGERY TOOK PLACE BECAUSE THE PATIENT HAD AN INFECTION AND THE SCREWS BECAME LOOSE. SURGERY WAS NOT DELAYED THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FRAGMENTS WERE GENERATED. THIS REPORT INVOLVES ONE (1) SINGLE-INNER SETSCREW. THIS IS REPORT 5 OF 10 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 19335309 ↗
• InjuryMay 16, 2024Device Slipped; Device Slipped

  ON (B)(6) 2024, AN EXP 5.5 REVISION SURGERY TOOK PLACE AT THE HOSPITAL. DURING THIS SURGERY IT WAS DISCOVERED THAT ALL EIGHT EXP INNIES WERE LOOSE. THE REVISION SURGERY TOOK PLACE BECAUSE THE PATIENT HAD AN INFECTION AND THE SCREWS BECAME LOOSE. SURGERY WAS NOT DELAYED THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FRAGMENTS WERE GENERATED. THIS REPORT INVOLVES ONE (1) SINGLE-INNER SETSCREW. THIS IS REPORT 4 OF 10 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 19335147 ↗
• InjuryMay 16, 2024Device Slipped; Device Slipped

  ON (B)(6) 2024, AN EXP 5.5 REVISION SURGERY TOOK PLACE AT THE HOSPITAL. DURING THIS SURGERY IT WAS DISCOVERED THAT ALL EIGHT EXP INNIES WERE LOOSE. THE REVISION SURGERY TOOK PLACE BECAUSE THE PATIENT HAD AN INFECTION AND THE SCREWS BECAME LOOSE. SURGERY WAS NOT DELAYED THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FRAGMENTS WERE GENERATED. THIS REPORT INVOLVES ONE (1) SINGLE-INNER SETSCREW. THIS IS REPORT 3 OF 10 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 19335081 ↗
• InjuryMay 16, 2024Device Slipped; Device Slipped

  ON (B)(6) 2024, AN EXP 5.5 REVISION SURGERY TOOK PLACE AT THE HOSPITAL. DURING THIS SURGERY IT WAS DISCOVERED THAT ALL EIGHT EXP INNIES WERE LOOSE. THE REVISION SURGERY TOOK PLACE BECAUSE THE PATIENT HAD AN INFECTION AND THE SCREWS BECAME LOOSE. SURGERY WAS NOT DELAYED THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FRAGMENTS WERE GENERATED. THIS REPORT INVOLVES ONE (1) SINGLE-INNER SETSCREW. THIS IS REPORT 2 OF 10 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 19335045 ↗
• InjuryApr 23, 2024Device Slipped; Device Slipped

  IT WAS REPORTED THAT ON APRIL 4, 2024 THE SET SCREWS WERE LOOSE POST OP. THE PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. THIS REPORT IS FOR ONE (1) EXP SINGLE-INNIE SETSCREW THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19169272 ↗
• InjuryApr 23, 2024Device Slipped; Device Slipped

  IT WAS REPORTED THAT ON (B)(6) 2024, THE SET SCREWS WERE LOOSE POST OP. THE PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. THIS REPORT IS FOR ONE (1) EXP SINGLE-INNIE SETSCREW. THIS IS REPORT 1 OF 2 FOR COMPLAINT: (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19169063 ↗
• InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A DATABASE RELATED RESEARCH ACTIVITY (DRRA): SPINE TANGO SOA REPORT - TLIF. THE FOLLOWING COMPLICATIONS HAVE BEEN IDENTIFIED: WOUND HEALING PROBLEM. COMPLICATION TIME/INTERVENTION. REPEAT SURGERY. THIS IS FOR DEPUY SYNTHES SPINE EXPEDIUM /OTHER, VIPER /OTHER AND VIPER CFX FENESTRATED PRODUCTS. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Impaired Healing

  MAUDE report 18465899 ↗
• InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A DATABASE RELATED RESEARCH ACTIVITY (DRRA): SPINE TANGO SOA REPORT - TLIF THE FOLLOWING COMPLICATIONS HAVE BEEN IDENTIFIED: NON-UNION. COMPLICATION TIME/INTERVENTION. REPEAT SURGERY. THIS IS FOR DEPUY SYNTHES SPINE CONDUIT TLIF ,CONFIDENCE SPINAL CEMENT SYSTEM, EXPEDIUM /OTHER AND VIPER CFX FENESTRATED PRODUCTS. THIS IS REPORT 5 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 18464860 ↗
• InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A DATABASE RELATED RESEARCH ACTIVITY (DRRA): SPINE TANGO SOA REPORT - TLIF. THE FOLLOWING COMPLICATIONS HAVE BEEN IDENTIFIED: POSTOPERATIVE INFECTION DEEP COMPLICATION TIME/INTERVENTION REPEAT SURGERY THIS IS FOR DEPUY SYNTHES SPINE EXPEDIUM /OTHER, MOSS MIAMI SI /OTHER AND VIPER CFX FENESTRATED PRODUCTS. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 18464561 ↗
• InjuryJan 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A DATABASE RELATED RESEARCH ACTIVITY (DRRA): SPINE TANGO SOA REPORT - TLIF THE FOLLOWING COMPLICATIONS HAVE BEEN IDENTIFIED: ADJACENT SEGMENT PATHOLOGY COMPLICATION TIME/INTERVENTION REPEAT SURGERY THIS IS FOR DEPUY SYNTHES SPINE EXPEDIUM /OTHER AND VIPER PRIME CFX FENESTRATED PRODUCTS. THIS IS REPORT 4 OF 7 FOR COMPLAINT (B)(6).

  Patient problems: Osteolysis

  MAUDE report 18453115 ↗
• InjurySep 22, 2023Device Slipped; Adverse Event Without Identified Device or Use Problem; Device Slipped; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS FOR ONE (1) SINGLE-INNER SETSCREW. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction; Metal Related Pathology

  MAUDE report 17799016 ↗
• MalfunctionAug 1, 2023Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT IN AN UNKNOWN DATE AND MONTH IN 2023, THE BELOW PROSTHESIS THREADS STRIPPED WHILE CONSULTANT TIGHTENED THE SCREW. REPLACEMENT SCREWS WERE OPENED. NO DELAYS, NO PATIENT ISSUES. THIS REPORT IS FOR ONE (1) EXPEDIUM SPINE SYSTEM SINGLE INNER SET SCREW 5.5. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17434923 ↗
• MalfunctionJul 25, 2023Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM THE UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023, AN EXPEDIUM SINGLE INNER SET SCREW WAS DAMAGED. THE THREADS STRIPPED WHILE THE SCREW WAS BEING TIGHTENED. A REPLACEMENT SCREW WAS OPENED FOR USE. PROCEDURE WAS COMPLETED WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A SINGLE-INNER SETSCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17392743 ↗
• MalfunctionFeb 24, 2023Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT THEY HAD X1 INSTRUMENT AND X1 IMPLANTS FAULTY WHICH BOTH NEED REPLACEMENT. EXPEDUIM SPINE SYSTEM SINGLE INNER SET SCREW LOT 353428, STRIPED DURING FINAL TIGHTENING, ITEM REMOVED AND DISCARDED. FINAL TIGHTENER, SHAFT TIP DAMAGED POSSIBLE DUE TO OLD AGE, CAUSING DAMAGE TO SCREW HEADS, NEEDED URGENT REPLACEMENT. NO PATIENT DELAY. THIS REPORT IS FOR ONE (1) SINGLE-INNER SETSCREW THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16439390 ↗
• MalfunctionFeb 13, 2023Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DRIVER TIP WAS NOT ENGAGING INTO THE SCREW HEAD. THE THREADS WITHIN THE EXPEDIUM SINGLE INNER SET SCREW WERE CROSS THREADED. THE SCREW WAS REMOVED WITHOUT ANY DELAY AND WAS DISCARDED. THE PATIENT WAS NOT AFFECTED, AND THERE WAS NO DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM SINGLE INNER SET SCREW 5.5. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16364350 ↗
• MalfunctionJan 11, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SURGEON COMPLAINED THAT THE INSTRUMENT WAS SPINNING IN SET SCREW HEAD AND WAS UNABLE TO REACH TORQUE LIMIT. A SUITABLE ALTERNATIVE INSTRUMENT WAS USED AND THE PROCEDURE COMPLETED SAFELY. ONE OF THE SET SCREWS STRIPPED WHILST ATTEMPTING TO FINAL TIGHTEN THE CONSTRUCT. THIS WAS REMOVED AND DISCARDED, AND A REPLACEMENT IMPLANT USED. NO IMPACT TO THE PATIENT. THERE WAS A 5 MINUTE DELAY IN THE PROCEDURE WITH NO IMPACT TO THE PATIENT. THIS REPORT IS FOR ONE (1) SINGLE-INNER SETSCREW. THIS IS REPORT 1 OF 1 FOR COMPLAINT: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16137480 ↗
• MalfunctionJul 21, 2022Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE SURGEON REPORTED THAT THE INSTRUMENT WAS SPINNING IN SET SCREW HEAD AND WAS UNABLE TO REACH TORQUE LIMIT. THIS HAPPENED TO MULTIPLE INSTRUMENTS, UNTIL A SUITABLE ALTERNATIVE INSTRUMENT WAS USED AND THE PROCEDURE COMPLETED SAFELY. ONE OF THE SET SCREWS STRIPPED WHILST ATTEMPTING TO FINAL TIGHTEN THE CONSTRUCT. THIS WAS REMOVED AND DISCARDED, AND A REPLACEMENT IMPLANT USED. NO IMPACT TO THE PATIENT. THERE WAS A 5 MINUTE DELAY IN SURGERY. THIS REPORT IS FOR ONE SINGLE-INNER SETSCREW. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15077659 ↗
• MalfunctionJul 8, 2022Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022 DURING A PRIMARY SCOLIOSIS PROCEDURE, THE INNER THREADS OF TWO (2) SETSCREWS STRIPPED DURING USE. THERE WAS NO PATIENT IMPACT AND NO SURGICAL DELAYS. THIS REPORT IS FOR ONE (1) SINGLE-INNER SETSCREW. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14961326 ↗