EXPEDIUM 179712655Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705034067759), received between Mar 7, 2018 and Oct 31, 2025 — classified as 6 injuries.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryOct 31, 2025Break; Break

  IT WAS REPORTED THE PATIENT UNDERWENT THE ORIGINAL PROCEDURE IN 2023. SINCE THEN, IT WAS NOTED THE SCREW IS CRACKED AND PATIENT NEEDS TO UNDERGO A REVISION PROCEDURE TO CORRECT IT.

  Patient problems: Insufficient Information

  MAUDE report 23437749 ↗
• 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 5 OF 5 FOR COMPLAINT (B)(6).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 18467189 ↗
• 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 55MM (B)(4).

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

  MAUDE report 18455948 ↗
• 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: ADJACENT SEGMENT PATHOLOGY, POSTOPERATIVE INFECTION DEEP, POSTOPERATIVE INFECTION SUPERFICIAL, WOUND HEALING PROBLEM COMPLICATION TIME/INTERVENTION REPEAT SURGERY THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM SI POLYAXIAL SCREW 5.5 X 6 X 55MM. THIS IS REPORT 2 OF 3 FOR (B)(4).

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

  MAUDE report 18453645 ↗
• 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 55MM. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Joint Laxity; Nerve Damage

  MAUDE report 18447601 ↗
• InjuryMar 7, 2018Fracture; Fracture

  IT WAS REPORTED VIA SUS VOLUNTARY EVENT REPORT VIA FDA. I NEED YOUR HELP. SINCE A DEFECT PEDICLE SCREW FROM THE COMPANY DEPUY SYNTHES WITH A HAIRLINE FRACTURE WAS IMPLANTED INTO MY LUMBAR SPINE I AM CONFINED TO A WHEELCHAIR AND CAN NO LONGER WORK AS A MEDICAL DOCTOR IN MY OWN MEDICAL PRACTICE. THE OPERATION WAS INTENDED TO STABILIZE MY LUMBAR SPINE WITH A SPONDYLODESIS USING PEDICLE SCREWS. THE MANUFACTURER OF THESE PEDICLE SCREW IS THE COMPANY DEPUY SYNTHES CAUSED PERMANENT NERVE DAMAGE. ONE OF THE IMPLANTED PEDICLE SCREWS HAD A HAIRLINE FRACTURE. THIS CRACK WAS CONFIRMED BY XRAY AND BY THE OPERATING SURGEON BY PALPATION. HE COULD FEEL THE CRACK AS HE REMOVED THE PEDICLE SCREW DURING THE REVISION SURGERY. THE FACT OF A HAIRLINE FRACTURE IS REPORTED IN THE OPERATION REPORT AND IN THE RELEASE REPORT. I ALREADY REPORTED THIS TO THE (B6) THE (B6) REGULATING AUTHORITY THAT CORRESPONDS TO THE FDA IN THE USA. NEWLY OCCURRED KNEE EXTENSOR PALSY RIGHT ON THE 3RD POSTOPERATIVE DAY. HAIRLINE FRACTURE OF THE PEDICLE LWK4 RIGHT WITH NERVE IRRITATION OF THE L4 NERVE ROOT ON THE RIGHT SIDE INTRASPINAL HEMATOMA L3-4 EXTENDING CAUDALLY SINCE I CAN NO LONGER WORK AS A MEDICAL DOCTOR IN MY OWN MEDIC

  Patient problems: Nerve Damage; Pain; Paralysis

  MAUDE report 7320697 ↗