EXPEDIUM 179722000Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10705034070070), received between Sep 11, 2018 and May 10, 2024 — classified as 23 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (6 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryMay 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REMOVAL OF HARDWARE DUE TO INFECTION ON (B(6) 2024. FOUR SCREWS, 3 LATERAL CONNECTORS, AND 7 SET SCREWS WERE REMOVED. THIS REPORT INVOLVES ONE EXP DUAL-INNER SETSCREW FOR (B)(4). ADDITIONAL IMPACTED PRODUCTS RELATED TO THIS EVENT ARE CAPTURED IN (B)(4). ADDITIONALLY, (B)(4) CAPTURES AN INSTRUMENT MALFUNCTION THAT OCCURRED DURING THE REMOVAL SURGERY.

  Patient problems: Unspecified Infection

  MAUDE report 19286186 ↗
• InjuryMay 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REMOVAL OF HARDWARE DUE TO INFECTION ON (B)(6) 2024. FOUR SCREWS, 3 LATERAL CONNECTORS, AND 7 SET SCREWS WERE REMOVED. THIS REPORT INVOLVES ONE UNK - RODS: EXPEDIUM FOR (B)(4). ADDITIONAL IMPACTED PRODUCTS RELATED TO THIS EVENT ARE CAPTURED IN (B)(4). ADDITIONALLY, (B)(4) CAPTURES AN INSTRUMENT MALFUNCTION THAT OCCURRED DURING THE REMOVAL SURGERY.

  Patient problems: Unspecified Infection

  MAUDE report 19286033 ↗
• 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: ADJACENT SEGMENT PATHOLOGY, INSTABILITY, OTHER, COMPLICATION TIME/INTERVENTION, REPEAT SURGERY. THIS IS FOR DEPUY SYNTHES SPINE EXPEDIUM /OTHER, EXPEDIUM POLYAXIAL AND EXPEDIUM 5.5 PRODUCTS. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information; Joint Laxity; Osteolysis

  MAUDE report 18464404 ↗
• 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: ADJACENT SEGMENT PATHOLOGY, NON-UNION. COMPLICATION TIME/INTERVENTION. REPEAT SURGERY. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM DUAL INNER SET SCREW 5.5. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture; Osteolysis

  MAUDE report 18462975 ↗
• InjuryJan 5, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  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: FAILURE TO REACH THERAPEUTIC GOALS, IMPLANT FAILURE, INSTABILITY, NON-UNION COMPLICATION TIME/INTERVENTION REPEAT SURGERY. THIS IS FOR DEPUY SYNTHES SPINE EXPEDIUM /OTHER, EXPEDIUM 5.5 AND EXPEDIUM POLYAXIAL PRODUCTS (EXP DUAL-INNER SETSCREW (B)(4) ).

  Patient problems: Insufficient Information; Joint Laxity; Nonunion/Delayed-union Bone Fracture

  MAUDE report 18456694 ↗
• InjuryJan 5, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  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: FAILURE TO REACH THERAPEUTIC GOALS, IMPLANT FAILURE, INSTABILITY, NON-UNION COMPLICATION TIME/INTERVENTION REPEAT SURGERY THIS IS FOR DEPUY SYNTHES SPINE EXPEDIUM /OTHER, EXPEDIUM 5.5 AND EXPEDIUM POLYAXIAL PRODUCTS (EXP DUAL-INNER SETSCREW (B)(4).

  Patient problems: Insufficient Information; Joint Laxity; Nonunion/Delayed-union Bone Fracture

  MAUDE report 18456594 ↗
• 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: NON-UNION, SPINAL IMBALANCE. COMPLICATION TIME/INTERVENTION. REPEAT SURGERY. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM DUAL INNER SET SCREW 5.5. THIS IS REPORT 4 OF 6 FOR (B)(4).

  Patient problems: Joint Laxity; Nonunion/Delayed-union Bone Fracture

  MAUDE report 18452913 ↗
• InjuryJan 5, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  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: NERVE ROOT DAMAGE, IMPLANT FAILURE COMPLICATION TIME/INTERVENTION INTRAOPERATIVE, REPEAT SURGERY THIS IS FOR DEPUY SYNTHES SPINE EXPEDIUM /OTHER, EXPEDIUM 5.5 AND EXPEDIUM POLYAXIAL PRODUCTS THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information; Nerve Damage

  MAUDE report 18451062 ↗
• InjuryAug 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT HAD SUFFERED FROM THE ADJACENT DISEASE. ON (B)(6) 2021 A REVISION SURGERY WAS PERFORMED WITHOUT FURTHER ISSUE. THE PRIMARY PROCEDURE WAS PERFORMED IN 2008 AND EXPEDIUM DI WAS APPLIED. THIS COMPLAINT INVOLVES TWENTY (20) DEVICES. THIS REPORT INVOLVES ONE (1) EXP DUAL-INNER SETSCREW. THIS IS REPORT 6 OF 20 FOR (B)(4).

  Patient problems: Osteolysis

  MAUDE report 12373705 ↗
• InjuryAug 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT HAD SUFFERED FROM THE ADJACENT DISEASE. ON (B)(6) 2021 A REVISION SURGERY WAS PERFORMED WITHOUT FURTHER ISSUE. THE PRIMARY PROCEDURE WAS PERFORMED IN 2008 AND EXPEDIUM DI WAS APPLIED. THIS COMPLAINT INVOLVES TWENTY (20) DEVICES. THIS REPORT INVOLVES ONE (1) EXP DUAL-INNER SETSCREW. THIS IS REPORT 8 OF 20 FOR (B)(4).

  Patient problems: Osteolysis

  MAUDE report 12373643 ↗
• InjuryAug 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT HAD SUFFERED FROM THE ADJACENT DISEASE. ON (B)(6) 2021 A REVISION SURGERY WAS PERFORMED WITHOUT FURTHER ISSUE. THE PRIMARY PROCEDURE WAS PERFORMED IN 2008 AND EXPEDIUM DI WAS APPLIED. THIS COMPLAINT INVOLVES TWENTY (20) DEVICES. THIS REPORT INVOLVES ONE (1) EXP DUAL-INNER SET SCREW. THIS IS REPORT 7 OF 20 FOR (B)(4).

  Patient problems: Osteolysis

  MAUDE report 12373629 ↗
• InjuryAug 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT HAD SUFFERED FROM THE ADJACENT DISEASE. ON (B)(6) 2021 A REVISION SURGERY WAS PERFORMED WITHOUT FURTHER ISSUE. THE PRIMARY PROCEDURE WAS PERFORMED IN 2008 AND EXPEDIUM DI WAS APPLIED. THIS COMPLAINT INVOLVES TWENTY (20) DEVICES. THIS REPORT INVOLVES ONE (1) EXP DUAL-INNER SET SCREW. THIS IS REPORT 7 OF 20 FOR (B)(4).

  Patient problems: Osteolysis

  MAUDE report 12373529 ↗
• InjuryAug 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT HAD SUFFERED FROM THE ADJACENT DISEASE. ON (B)(6) 2021 A REVISION SURGERY WAS PERFORMED WITHOUT FURTHER ISSUE. THE PRIMARY PROCEDURE WAS PERFORMED IN 2008 AND EXPEDIUM DI WAS APPLIED. THIS COMPLAINT INVOLVES TWENTY (20) DEVICES. THIS REPORT INVOLVES ONE (1) EXP DUAL-INNER SETSCREW. THIS IS REPORT 4 OF 20 FOR (B)(4).

  Patient problems: Osteolysis

  MAUDE report 12373267 ↗
• InjuryMar 26, 2020Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THIS CASE IS LOGGED TO CAPTURE THE REMOVAL OF ILIAC SCREWS WHICH WAS MENTIONED ON (B)(4). THE PATIENT WAS SCHEDULED FOR REMOVAL OF ILIAC SCREWS FROM L4-PELVIS CONSTRUCT. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR ONE (1) EXP DUAL-INNER SETSCREW. THIS REPORT IS 5 OF 6 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9884122 ↗
• InjuryMar 26, 2020Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THIS CASE IS LOGGED TO CAPTURE THE REMOVAL OF ILIAC SCREWS WHICH WAS MENTIONED ON (B)(4). THE PATIENT WAS SCHEDULED FOR REMOVAL OF ILIAC SCREWS FROM L4-PELVIS CONSTRUCT. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR ONE (1) EXP DUAL-INNER SET SCREW. THIS REPORT IS 2 OF 6 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9884101 ↗
• InjuryDec 11, 2019Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE RODS FRACTURED AT T12 LEVEL AND SCREWS BROKEN AT L5 LEVEL. REVISION SURGERY TO REPLACE RODS AND EXTEND CONSTRUCT TO S1 AND PELVIS WAS PERFORMED. NO PROBLEMS DURING PROCEDURE. THIS REPORT IS FOR ONE (1) EXP DUAL-INNER SETSCREW. THIS IS REPORT 7 OF 8 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9452899 ↗
• InjuryJan 22, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  THE FOLLOWING WAS REPORTED: REVISION: DR. (B)(6) HOSPITAL (B)(6) 2018. PATIENT HAS DEMENTIA WHICH HAS ESCALATED SINCE PRIMARY SURGERY DATED (B)(6) 2018. THE DEMENTIA HAS LEAD TO POOR DIET AIDING IN A PSEUDOARTHROSIS (NON-FUSION). A RECENT FALL THEN LOOSENED THE PRE EXISTING CONSTRUCT. PRIMARY SCREWS REMOVED AND REPLACED WITH NEW SCREWS FOR NEW FIXATION. FEMALE PATIENT INITIALS (B)(6).

  Patient problems: Fall; No Code Available

  MAUDE report 8266330 ↗
• InjurySep 24, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT CUSTOMER SERVICE WAS CONTACTED BY A PATIENT THAT ASKED WHICH MATERIALS THE IMPLANTS ARE MADE OF. THE PATIENT HAD SPINE SURGERY IN (B)(6) 2017. ON 30AUG2018: PER ADDITIONAL INFORMATION FROM LOC, SUSPECTED ALLERGIC REACTION TO EXPEDIUM SCREWS (LUMBAR). THE PATIENT NEEDS TO KNOW WHAT METALS COMPOUND THE TITANIUM ALLOY.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 7903203 ↗
• InjurySep 11, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  THE FOLLOWING WAS REPORTED: REVISION: DR. (B)(6) PRIVATE HOSPITAL (B)(6) 2018. PATIENT HAS DEMENTIA WHICH HAS ESCALATED SINCE PRIMARY SURGERY DATED (B)(6) 2018. THE DEMENTIA HAS LEAD TO POOR DIET AIDING IN A PSEUDOARTHROSIS (NON-FUSION). A RECENT FALL THEN LOOSENED THE PRE EXISTING CONSTRUCT. PRIMARY SCREWS REMOVED AND REPLACED WITH NEW SCREWS FOR NEW FIXATION. FEMALE PATIENT INITIALS (B)(6).

  Patient problems: Spinal Column Injury

  MAUDE report 7865113 ↗
• InjurySep 11, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  THE FOLLOWING WAS REPORTED: REVISION: DR. (B)(6); (B)(6), (B)(6) 2018. PATIENT HAS DEMENTIA WHICH HAS ESCALATED SINCE PRIMARY SURGERY DATED (B)(6) 2018. THE DEMENTIA HAS LEAD TO POOR DIET AIDING IN A PSEUDOARTHROSIS (NON-FUSION). A RECENT FALL THEN LOOSENED THE PRE EXISTING CONSTRUCT. PRIMARY SCREWS REMOVED AND REPLACED WITH NEW SCREWS FOR NEW FIXATION. FEMALE PATIENT INITIALS C.S.

  Patient problems: Spinal Column Injury

  MAUDE report 7865070 ↗
• InjurySep 11, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  THE FOLLOWING WAS REPORTED: REVISION: DR. (B)(6) PRIVATE HOSPITAL (B)(6) 2018. PATIENT HAS DEMENTIA WHICH HAS ESCALATED SINCE PRIMARY SURGERY DATED (B)(6) 2018. THE DEMENTIA HAS LEAD TO POOR DIET AIDING IN A PSEUDOARTHROSIS (NON-FUSION). A RECENT FALL THEN LOOSENED THE PRE EXISTING CONSTRUCT. PRIMARY SCREWS REMOVED AND REPLACED WITH NEW SCREWS FOR NEW FIXATION. FEMALE PATIENT INITIALS (B)(6).

  Patient problems: Spinal Column Injury

  MAUDE report 7865034 ↗
• InjurySep 11, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  THE FOLLOWING WAS REPORTED: REVISION: DR. (B)(6) PRIVATE HOSPITAL (B)(6) 2018. PATIENT HAS DEMENTIA WHICH HAS ESCALATED SINCE PRIMARY SURGERY DATED: (B)(6) 2018. THE DEMENTIA HAS LEAD TO POOR DIET AIDING IN A PSEUDOARTHROSIS (NON-FUSION). A RECENT FALL THEN LOOSENED THE PRE EXISTING CONSTRUCT. PRIMARY SCREWS REMOVED AND REPLACED WITH NEW SCREWS FOR NEW FIXATION. FEMALE PATIENT INITIALS (B)(6).

  Patient problems: Spinal Column Injury

  MAUDE report 7864967 ↗
• InjurySep 11, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  THE FOLLOWING WAS REPORTED: REVISION: DR. (B)(6); (B)(6) HOSPITAL (B)(6) 2018. PATIENT HAS DEMENTIA WHICH HAS ESCALATED SINCE PRIMARY SURGERY DATED (B)(6) 2018. THE DEMENTIA HAS LEAD TO POOR DIET AIDING IN A PSEUDOARTHROSIS (NON-FUSION). A RECENT FALL THEN LOOSENED THE PRE EXISTING CONSTRUCT. PRIMARY SCREWS REMOVED AND REPLACED WITH NEW SCREWS FOR NEW FIXATION. FEMALE PATIENT (B)(6).

  Patient problems: Spinal Column Injury

  MAUDE report 7864377 ↗