EXPEDIUM 179712650Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10705034067742), received between Nov 20, 2017 and Sep 23, 2024 — classified as 27 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 31 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT REVISION SURGERY DUE TO SCREWS AND CAGE NONUNION. THE DOCTOR WAS BLAMING THE FIBERGRAFT PUTTY AND AERIDYAN MATRIX FOR NONUNION OF CASE DONE IN 2021. THE DOCTOR DID NOT START USING FIBERGRAFT/AERIDYAN UNTIL (B)(6) 2023. PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT IS RELATED TO (B)(4) WHICH CAPTURES ADDITIONAL DEVICES.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 20280770 ↗
• InjurySep 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT REVISION SURGERY DUE TO SCREWS AND CAGE NONUNION. THE DOCTOR WAS BLAMING THE FIBERGRAFT PUTTY AND AERIDYAN MATRIX FOR NONUNION OF CASE DONE IN 2021. THE DOCTOR DID NOT START USING FIBERGRAFT/AERIDYAN UNTIL (B)(6) 2023. PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT IS RELATED TO (B)(4) WHICH CAPTURES ADDITIONAL DEVICES.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 20280698 ↗
• InjurySep 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT REVISION SURGERY DUE TO SCREWS AND CAGE NONUNION. THE DOCTOR WAS BLAMING THE FIBERGRAFT PUTTY AND AERIDYAN MATRIX FOR NONUNION OF CASE DONE IN 2021. THE DOCTOR DID NOT START USING FIBERGRAFT/AERIDYAN UNTIL (B)(6) 2023. PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT IS RELATED TO (B)(4) WHICH CAPTURES ADDITIONAL DEVICES.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 20280696 ↗
• InjurySep 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A REVISION OCCURRED ON (B)(6) 2024 DUE TO NONUNION. SCREWS AND CAGE WERE EXPLANTED. PATIENT OUTCOME WAS UNKNOWN. ORIGINAL DATE OF SURGERY UNKNOWN DATE IN 2021.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 20271250 ↗
• InjurySep 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A REVISION OCCURRED ON (B)(6) 2024 DUE TO NONUNION. SCREWS AND CAGE WERE EXPLANTED. PATIENT OUTCOME WAS UNKNOWN. ORIGINAL DATE OF SURGERY UNKNOWN DATE IN 2021.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 20270976 ↗
• InjurySep 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A REVISION OCCURRED ON (B)(6) 2024 DUE TO NONUNION. SCREWS AND CAGE WERE EXPLANTED. PATIENT OUTCOME WAS UNKNOWN. ORIGINAL DATE OF SURGERY UNKNOWN DATE IN 2021.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 20270877 ↗
• InjurySep 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A REVISION OCCURRED ON (B)(6) 2024 DUE TO NONUNION. SCREWS AND CAGE WERE EXPLANTED. PATIENT OUTCOME WAS UNKNOWN. ORIGINAL DATE OF SURGERY UNKNOWN DATE IN 2021.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 20270652 ↗
• InjurySep 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A REVISION OCCURRED ON (B)(6) 2024 DUE TO NONUNION. SCREWS AND CAGE WERE EXPLANTED. PATIENT OUTCOME WAS UNKNOWN. ORIGINAL DATE OF SURGERY UNKNOWN DATE IN 2021

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 20270347 ↗
• InjurySep 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A REVISION OCCURRED ON (B)(6) 2024 DUE TO NONUNION. SCREWS AND CAGE WERE EXPLANTED. PATIENT OUTCOME WAS UNKNOWN. ORIGINAL DATE OF SURGERY UNKNOWN DATE IN 2021.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 20269397 ↗
• InjurySep 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A REVISION OCCURRED ON (B)(6) 2024 DUE TO NONUNION. SCREWS AND CAGE WERE EXPLANTED. PATIENT OUTCOME WAS UNKNOWN. ORIGINAL DATE OF SURGERY UNKNOWN DATE IN 2021

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 20269148 ↗
• InjurySep 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A REVISION OCCURRED ON (B)(6) 2024 DUE TO NONUNION. SCREWS AND CAGE WERE EXPLANTED. PATIENT OUTCOME WAS UNKNOWN. ORIGINAL DATE OF SURGERY UNKNOWN DATE IN 2021

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 20269051 ↗
• InjurySep 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A REVISION OCCURRED ON (B)(6) 2024 DUE TO NONUNION. SCREWS AND CAGE WERE EXPLANTED. PATIENT OUTCOME WAS UNKNOWN. ORIGINAL DATE OF SURGERY UNKNOWN DATE IN 2021.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 20268993 ↗
• 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 EXPEDIUM /OTHER ,EXPEDIUM POLYAXIAL AND VIPER CFX FENESTRATED PRODUCTS. THIS IS REPORT 4 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 18467084 ↗
• 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: HARDWARE REMOVAL, WOUND HEALING PROBLEM. COMPLICATION TIME/INTERVENTION. REPEAT SURGERY. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM SI POLYAXIAL SCREW 5.5 X 6 X 50MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Impaired Healing; Insufficient Information

  MAUDE report 18466312 ↗
• 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: FAILURE TO REACH THERAPEUTIC GOALS, NEUROCOMPRESSION. COMPLICATION TIME/INTERVENTION. REPEAT SURGERY. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM SI POLYAXIAL SCREW 5.5 X 6 X 50MM. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Insufficient Information; Nerve Damage

  MAUDE report 18463406 ↗
• InjuryJan 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 IS FOR DEPUY SYNTHES SPINE EXPEDIUM /OTHER AND EXPEDIUM POLYAXIAL PRODUCTS (SI POLYAXL SCREW 6 X 50MM (B)(4).)

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

  MAUDE report 18455937 ↗
• 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 SI POLYAXIAL SCREW 5.5 X 6 X 50MM THIS IS REPORT 6 OF 6 FOR (B)(4).

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

  MAUDE report 18452547 ↗
• InjuryJan 5, 2024Migration; Migration

  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: FAILURE TO REACH THERAPEUTIC GOALS, IMPLANT FAILURE, IMPLANT MALPOSITION, INSTABILITY COMPLICATION TIME/INTERVENTION REPEAT SURGERY THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM SI POLYAXIAL SCREW 5.5 X 6 X 50MM THIS IS REPORT 3 OF 5 FOR (B)(4).

  Patient problems: Insufficient Information; Joint Laxity

  MAUDE report 18452077 ↗
• 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: WOUND HEALING PROBLEM. COMPLICATION TIME/INTERVENTION. REPEAT SURGERY. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM SI POLYAXIAL SCREW 5.5 X 6 X 50MM. THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: Impaired Healing

  MAUDE report 18451348 ↗
• 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: INSTABILITY. COMPLICATION TIME/INTERVENTION. REPEAT SURGERY. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM SI POLYAXIAL SCREW 5.5 X 6 X 50MM. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: Joint Laxity

  MAUDE report 18449985 ↗
• InjuryJan 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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: INSTABILITY, NEUROCOMPRESSION. COMPLICATION TIME/INTERVENTION. REPEAT SURGERY. THIS REPORT IS FOR ONE (1) SI POLYAXL SCREW 6 X 50MM . THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Joint Laxity; Nerve Damage

  MAUDE report 18447532 ↗
• MalfunctionMay 3, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE EXPEDIUM SCREW WOULD NOT ACCEPT A SET SCREW WITHOUT STRIPPING. ACCORDING TO THE REPORT, THE SURGEON REMOVED A SCREW AND PUT A NEW ONE IN AND UPON CHECKING THEY JUST LOOK LIKE A THREAD THAT WAS PROTRUDING OUT. IT WAS FURTHER REPORTED THAT THE LITTLE PROTRUDING PROHIBITED THE SET SCREW FROM SCREWING INTO THE SCREW HEAD. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF TWO MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) SI POLYAXL SCREW 6 X 50MM DEVICE. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14269314 ↗
• MalfunctionJul 30, 2019Break; Break

  IT WAS REPORTED THAT ON JUNE 4, 2019, DURING SPINAL FUSION SURGERY, AFTER INSERTION OF ACIS PROTI, THE SURGEON REMOVED THE CAGE INSERTER AND THEN USED A PUSHER TO SLIGHTLY IMPACT A LITTLE DEEPER. ON THE FINAL X-RAY, THEY EXAMINED A CRACK IN THE CAGE AND OBSERVED THAT IT WAS SPLIT. THEY EASILY REMOVED THE TWO (2) PARTS AND PLACED A NEW ONE. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8843187 ↗
• MalfunctionJul 8, 2019Break; Break

  IT WAS REPORTED THAT THE INNER PRESSED-IN SLEEVE HAS BEEN RELEASED POST OP DID THE PATIENT EXPERIENCE A POST-OP DEVICE MALFUNCTION? --> UNKNOWN, DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? --> UNKNOWN, DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? --> UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES --> YES, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)?--> REVISION SURGERY, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: --> UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY --> UNKNOWN, (B)(4) DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST.--> TRUE THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8769183 ↗
• InjuryMay 3, 2019Break; Break

  IT WAS REPORTED THAT THE INNER PRESSED-IN SLEEVE HAS BEEN RELEASED POST OP.

  Patient problems: No Code Available

  MAUDE report 8578749 ↗