EXPEDIUM 179712745Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10705034067902), received between Aug 28, 2017 and Feb 29, 2024 — classified as 17 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 29, 2024Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON 25-DECEMBER-2021 AN UNKNOWN SURGERY FOR VERTEBRAL FRACTURE WAS PERFORMED. L1-L3 AND L4-S2 FUSION WAS PERFORMED DUE TO INJURY. AFTER THE INITIAL SURGERY, A REMOVAL SURGERY WAS PERFORMED ON (B)(6) 2024 BECAUSE OF THE CORRECTION LOSS FOUND ON L1-L3. L1-L3 FUSION WAS REMOVED. DURING THE REMOVAL SURGERY, IT WAS FOUND THAT THE SCREW IN QUESTION (L1 LEFT) BROKE AT THE BASE. THE SCREW WAS LEFT IN PLACE AND THE SURGERY WAS COMPLETED, AS THE SURGEON DETERMINED THAT THERE WAS NO PROBLEM WITH LEAVING THE BROKEN END INSIDE THE BODY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN EXPEDIUM SPINE SYSTEM SI POLYAXIAL SCREW 5.5 X 7 X 45MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18811240 ↗
• 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: WOUND INFECTION DEEP, WOUND INFECTION SUPERFICIAL. COMPLICATION TIME/INTERVENTION. POSTOPERATIVE (BEFORE DISCHARGE). THIS IS FOR DEPUY SYNTHES SPINE VIPER /OTHER AND EXPEDIUM POLYAXIAL PRODUCTS (SI POLYAXL SCREW 7 X 45MM (B)(4)).

  Patient problems: Post Operative Wound Infection

  MAUDE report 18454040 ↗
• InjuryJan 5, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (FCER) FROM A DATABASE RELATED RESEARCH ACTIVITY (DRRA): SPINE TANGO SOA REPORT - TLIF. THE FOLLOWING COMPLICATIONS HAVE BEEN IDENTIFIED: IMPLANT FAILURE, INSTABILITY, NON-UNION COMPLICATION TIME/INTERVENTION REPEAT SURGERY THIS REPORT IS FOR ONE (1) SI POLYAXL SCREW 7 X 45MM THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

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

  MAUDE report 18451669 ↗
• 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 7 X 45MM. THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: Impaired Healing

  MAUDE report 18451668 ↗
• 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, NEUROCOMPRESSION. COMPLICATION TIME/INTERVENTION. REPEAT SURGERY. THIS IS FOR DEPUY SYNTHES SPINE EXPEDIUM /OTHER, MOSS MIAMI SI /OTHER AND EXPEDIUM POLYAXIAL PRODUCTS. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Nerve Damage; Osteolysis

  MAUDE report 18451187 ↗
• InjuryJan 4, 2024Migration; Migration

  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, IMPLANT FAILURE, POSTOPERATIVE INFECTION DEEP, WOUND HEALING PROBLEM. COMPLICATION TIME/INTERVENTION. REPEAT SURGERY. THIS IS FOR DEPUY SYNTHES SPINE EXPEDIUM /OTHER AND EXPEDIUM POLYAXIAL AND VIPER CFX FENESTRATED PRODUCTS (SI POLYAXL SCREW 7 X 45MM FOR (B)(4).

  Patient problems: Impaired Healing; Insufficient Information; Osteolysis; Unspecified Infection

  MAUDE report 18443544 ↗
• InjuryJun 28, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, THERE WERE 2 SPINE SCREWS THAT WERE IN QUESTION. IT WAS FOUND THAT THE SCREWS WERE BROKEN. THE BROKEN HARDWARE WAS REMOVED FROM THE PATIENT. THIS REPORT INVOLVES ONE (1) EXPEDIUM SPINE SYSTEM SI POLYAXIAL SCREW 5.5 X 7 X 45MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 17216323 ↗
• InjurySep 15, 2022Break; Break

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, A REVISION SURGERY WAS PERFORMED TO REMOVE OSTEOSYNTHESIS MATERIAL OF THE SPINE (EXPEDIUM 5.5 SYSTEM) BECAUSE ONE OF THE SCREWS IMPLANTED IN THE PATIENT BROKE. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR AN EXPEDIUM SPINE SYSTEM SI POLYAXIAL SCREW 5.5 X 7 X 45MM. THIS IS REPORT 7 OF 9 FOR (B)(4).

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

  MAUDE report 15428051 ↗
• InjuryJun 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT A PRIMARY FUSION PROCEDURE (L3/4) ON (B)(6) 2011, AND LATER UNDERWENT A REVISION PROCEDURE AT A DIFFERENT HOSPITAL ON AN UNKNOWN DAY IN (B)(6) 2013. ON (B)(6) 2022, IT WAS REPORTED TO THE SALES REP THAT THE PATIENT WOULD UNDERGO A SECOND REVISION PROCEDURE TO REMOVE THE SCREWS AT L3/L4 AT THE HOSPITAL WHERE THE PRIMARY PROCEDURE WAS PERFORMED. THIS REPORT IS FOR AN EXPEDIUM SPINE SYSTEM SI POLYAXIAL SCREW 5.5 X 7 X 45MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

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

  MAUDE report 14803106 ↗
• InjuryJun 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT A PRIMARY FUSION PROCEDURE (L3/4) ON (B)(6) 2011, AND LATER UNDERWENT A REVISION PROCEDURE AT A DIFFERENT HOSPITAL ON AN UNKNOWN DAY IN (B)(6) 2013. ON (B)(6) 2022, IT WAS REPORTED TO THE SALES REP THAT THE PATIENT WOULD UNDERGO A SECOND REVISION PROCEDURE TO REMOVE THE SCREWS AT L3/L4 AT THE HOSPITAL WHERE THE PRIMARY PROCEDURE WAS PERFORMED. THIS REPORT IS FOR AN EXPEDIUM SPINE SYSTEM SI POLYAXIAL SCREW 5.5 X 7 X 45 MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

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

  MAUDE report 14803075 ↗
• InjuryDec 8, 2021Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT, PROCEDURE WAS REVISED DUE TO BACK PAIN AND CONNECTION DEGENERATION. THIS REPORT IS FOR ONE (1) SI POLYAXL SCREW 7 X 45MM. THIS IS REPORT 1 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: Osteolysis; Pain

  MAUDE report 12961907 ↗
• InjuryDec 8, 2021Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT, PROCEDURE WAS REVISED DUE TO BACK PAIN AND CONNECTION DEGENERATION. THIS REPORT IS FOR (1) SI POLYAXL SCREW 7 X 45MM. THIS IS REPORT 6 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: Osteolysis; Pain

  MAUDE report 12961853 ↗
• MalfunctionNov 23, 2021Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A METAL REMOVAL SURGERY ON (B)(6) 2021, DUE TO BACK PAIN AND CONNECTION DEGENERATION. DURING THE PROCEDURE, A SCREW BROKE AS THE SCREWDRIVER WAS INSERTED INTO THE SCREW HEAD. SCREW HEAD AND SHAFT WERE BOTH REMOVED FROM THE PATIENT. THE SCREW WAS REPLACED. THERE IS NO ALLEGATION AGAINST THE SCREWDRIVER. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN UNKNOWN SURGERY DELAY. THIS REPORT IS FOR A SI POLYAXL SCREW 7 X 45MM. THIS IS REPORT 1 OF 1 FOR (B)(4) AND CAPTURES THE SCREW BREAKAGE. PATIENT¿S PAIN AND REVISION SURGERY IS CAPTURED UNDER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12864928 ↗
• InjuryApr 12, 2019Break; Break

  THE FOLLOWING WAS REPORTED: REVISION T4-PELVIS & BROKEN PEDICLE SCREWS: DR (B)(6), (B)(6) HOSPITAL, (B)(6) 2019. PT HAD A POSTERIOR SPINAL FUSION FOR SPINAL DEFORMITY, T4-PELVIS (3/11/16). IT WAS QUITE A SIGNIFICANT DEFORMITY. IT WAS NOTED THAT THE RODS BROKE AT L1 (2018) WHERE THERE IS A NON-UNION. THIS IS STAGE 1 OF 2. THE RODS WERE REMOVED ON BOTH SIDES, BROKEN SCREWS REMOVED, NEW SCREWS IMPLANTED AND THEN NEW COCR RODS. TWO NEW SFX CROSS CONNECTORS WERE ALSO USED.

  Patient problems: No Code Available

  MAUDE report 8510341 ↗
• InjuryApr 12, 2019Break; Break

  THE FOLLOWING WAS REPORTED: REVISION T4-PELVIS & BROKEN PEDICLE SCREWS: DR (B)(6), NORTH (B)(6) HOSPITAL, (B)(6) 2019. PT HAD A POSTERIOR SPINAL FUSION FOR SPINAL DEFORMITY, T4-PELVIS ((B)(6) 2016). IT WAS QUITE A SIGNIFICANT DEFORMITY. IT WAS NOTED THAT THE RODS BROKE AT L1 (2018) WHERE THERE IS A NON-UNION. THIS IS STAGE 1 OF 2. THE RODS WERE REMOVED ON BOTH SIDES, BROKEN SCREWS REMOVED, NEW SCREWS IMPLANTED AND THEN NEW COCR RODS. TWO NEW SFX CROSS CONNECTORS WERE ALSO USED.

  Patient problems: No Code Available

  MAUDE report 8510285 ↗
• InjuryJan 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PLIF SURGERY WAS PERFORMED ON UNKNOWN DATE (ABOUT A YEAR AGO) TO FIX L4 WITH 7MM SCREW (P/N AND LOT NUMBER WERE UNKNOWN). AFTER ABOUT A YEAR FROM PRIMARY SURGERY, THE PATIENT¿S GOT ADJACENT SEGMENTAL DISEASES. THUS, THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2017 TO REPLACE 7MM SCREW TO 8MM SCREW. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

  Patient problems: No Code Available

  MAUDE report 8245027 ↗
• InjuryDec 21, 2018Loose or Intermittent Connection; Material Split, Cut or Torn; Loose or Intermittent Connection; Material Split, Cut or Torn

  IT WAS REPORTED THAT ACCORDING TO A STATEMENT OF THE USER, THE SCREW COULD NOT FIXED WITH SCREWDRIVER. THUS, THE SCREW WAS NOT "MONO-AXIAL" BUT MOVING DURING THE DISPOSAL. THIS SHOULD HAVE CAUSED A SUBSEQUENT SCREWS MALPOSITION.

  Patient problems: No Code Available; Pain

  MAUDE report 8189097 ↗
• InjuryJan 9, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  "SPINAL STENOSIS OF THE LUMBAR SPINE WITH CLAUDICATIOSPINALIS SYMPTOMS, TWO-SIDED FOOT WEAKNESS AND KNEE EXTENSORS PALSY LEFT. THESE ISSUES SHOULD BE HANDLED AND REPAIRED A SPINAL FUSION OPERATION. A VENTRAL INTERPOSITIONS SPINAL FUSION AT L5/S1 WAS CARRIED OUT FOR THIS PURPOSE. A DEFECTIVE PEDICLE SCREW WAS USED DURING THE OPERATION (L4), WHICH CAUSED A HEMORRHAGE AND NERVE COMPRESSION. THE REVISION SURGERY OF THE (B)(6) 2017 THE PEDICLE SCREW IN L4 REMOVED, BECAUSE IT SHOWED A FISSURE OF THE PEDICLE. HEMATOMA AT L4 AND L5 (RIGHT) HAVE BEEN ADDRESSED. THE SCREW IN L3 (RIGHT) HAS BEEN THROUGH A 5 MM LONGER BOLT REPLACED.

  Patient problems: Hematoma; Not Applicable

  MAUDE report 7174685 ↗
• InjuryAug 28, 2017Loose or Intermittent Connection; Loose or Intermittent Connection

  IMPLANT BROKE DURING INSERTION. COMPLAINT FORM SENT TO REP PER COMPLAINT FORM: WHEN PLACING THE REVISION SCREW, THE SCREWDRIVER MADE A POPPING NOISE WHICH WAS THE TIP OF THE DRIVER BREAKING. THE TIP WAS STUCK IN THE SCREW AND WE HAD TO ATTACH A ROD TO REMOVE. WE BROKE OFF THE HEAD OF THE SCREW ATTEMPTING TO REMOVE AND THEN USED A REVERSE THREADED REMOVAL TIP IN ORDER TO REMOVE THE SCREW SHAFT.

  Patient problems: Failure of Implant

  MAUDE report 6824422 ↗