EXPEDIUM 179762120Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705034077406), received between Nov 12, 2018 and Jan 8, 2024 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• 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 3 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 18466921 ↗
• 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 ROD 5.5 X 120MM. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Joint Laxity

  MAUDE report 18450707 ↗
• 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 2 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information; Nerve Damage

  MAUDE report 18449823 ↗
• MalfunctionDec 6, 2022No Apparent Adverse Event; No Apparent Adverse Event

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT HAD SURGERY DURING WHICH THE SCREW WAS IMPLANTED ON (B)(6) 2022. ON (B)(6) 2022, THE PATIENT HAD A REVISION SURGERY BECAUSE THE TWO (2) 6 X 50MM SCREWS WERE BROKEN AND THERE WAS A FRACTURE BETWEEN T11 & T12. THE SURGEON REMOVED THE WHOLE CONSTRUCT TO REPLACE SCREWS AND EXTENDED THE CONSTRUCT TO T9. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE IT WAS IDENTIFIED THAT ROD, 120MM WAS CUT. THIS DEVICE CONDITION WAS EVALUATED AND DETERMINED TO BE REPORTABLE ON NOVEMBER 18, 2022. THIS REPORT IS FOR ONE (1) ROD, 120MM. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15924984 ↗
• MalfunctionDec 6, 2022No Apparent Adverse Event; No Apparent Adverse Event

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT HAD SURGERY DURING WHICH THE SCREW WAS IMPLANTED ON (B)(6) 2022. ON (B)(6) 2022, THE PATIENT HAD A REVISION SURGERY BECAUSE THE TWO (2) 6 X 50MM SCREWS WERE BROKEN AND THERE WAS A FRACTURE BETWEEN T11 & T12. THE SURGEON REMOVED THE WHOLE CONSTRUCT TO REPLACE SCREWS AND EXTENDED THE CONSTRUCT TO T9. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE IT WAS IDENTIFIED THAT ROD, 120MM WAS CUT. THIS DEVICE CONDITION WAS EVALUATED AND DETERMINED TO BE REPORTABLE ON NOVEMBER 18, 2022. THIS REPORT IS FOR ONE (1) ROD, 120MM THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15924897 ↗
• InjuryMar 3, 2022Adverse 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 MAY 22 2018 THE PATIENT UNDERWENT THE PRIMARY POSTERIOR LUMBAR INTERBODY FUSION (PLIF) (L4-5). ON (B)(6) 2022 IT WAS FOUND THAT THE PATIENT HAD SUFFERED FROM ASD AND ON (B)(6) 2022 THE PATIENT IS SCHEDULED TO UNDERGO A REVISION PROCEDURE (PLIF EXTENSION BETWEEN L3-4). THE UPCOMING REVISION PROCEDURE WAS PLANNED TO REMOVE DEVICES IN QUESTION FROM THE LESION AND RECONNECTED FROM L3 AND TO DEPLOY SCREWS IN L4-5 WILL BE LEFT IN PLACE BECAUSE THEY HAVE BEEN TIGHT ENOUGH IN THE LESION. PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) SINGLE-INNER SETSCREW. THIS IS REPORT 5 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13660533 ↗
• 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) ROD, 120MM. THIS IS REPORT 20 OF 20 FOR (B)(4).

  Patient problems: Osteolysis

  MAUDE report 12374558 ↗
• InjuryNov 12, 2018Break; Break

  IT WAS REPORTED: PATIENT WITH A HISTORY OF POSTERIOR ARTHRODESIS OF COLUMN L4, S1 IN 2009; INSTRUMENTATION REVIEW, MAY 2018; INSTRUMENTATION REVISION BY BAR BREAK, OCTOBER 25, 2018 (S1 SCREW CHANGE AND TITANIUM BAR CHANGE PER COBALT CHROME BAR). (B)(6); SIZE: 1.53 CM; BACKGROUND: HYPERTENSION. PRODUCT INVOLVED: 179702000 BATCH 185456 NAILS SET S1; 179712640 BATCH 179935 POLIAXIAL NAIL SI 6X40; 179712735 BATCH AJNB97 POLIAXIAL NAIL SI 7X35; 179762120 BATCH VDL4W5R STICK 120.

  Patient problems: No Code Available

  MAUDE report 8061051 ↗