EXPEDIUM 179712740Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10705034067896), received between Sep 13, 2017 and Apr 15, 2024 — classified as 15 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (11 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryApr 15, 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. NO FURTHER DETAILS ARE AVAILABLE. THIS REPORT INVOLVES ONE UNK - SCREWS: EXPEDIUM. THIS IS REPORT 3 OF 4 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 19106982 ↗
• InjuryApr 15, 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. NO FURTHER DETAILS ARE AVAILABLE. THIS REPORT INVOLVES ONE UNK - SCREWS: EXPEDIUM. THIS IS REPORT 4 OF 4 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 19106981 ↗
• 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: INSTABILITY. COMPLICATION TIME/INTERVENTION. REPEAT SURGERY. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM SI POLYAXIAL SCREW 5.5 X 7 X 40MM. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: Joint Laxity

  MAUDE report 18463025 ↗
• 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: IMPLANT FAILURE, INSTABILITY, NON-UNION. COMPLICATION TIME/INTERVENTION. REPEAT SURGERY. THIS REPORT IS FOR ONE (1) SI POLYAXL SCREW 7 X 40MM. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

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

  MAUDE report 18450184 ↗
• 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 40MM FOR (B)(4).

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

  MAUDE report 18443486 ↗
• InjuryMar 10, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT A REVISION SURGERY FOR ADJACENT SEGMENT DISEASE (ASD). WHEN A SETSCREW AND A ROD AT L3 RIGHT WERE REMOVED, IT WAS FOUND THAT THE SCREW HAD BROKEN OFF. A FRAGMENT(S) WAS REMOVED FROM THE LESION, AND THE REST OF THE PROCEDURE WAS COMPLETED LESS THAN THIRTY (30) MINUTE SURGICAL DELAY. THE SURGEON NOTED THAT THE BONE FUSION WHERE A CAGE WAS DEPLOYED HAD NOT BEEN COMPLETED. THIS REPORT INVOLVES ONE (1) SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS PRODUCT COMPLAINT, (B)(4), IS RELATED TO (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; Nonunion/Delayed-union Bone Fracture

  MAUDE report 13723991 ↗
• InjuryFeb 24, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, A REVISION SURGERY WAS PERFORMED TO A L5-S1 (TLIF) WITH SCREWS FROM L4-S2. THE PATIENT HAD L5-S1 7X40 MM SCREWS, THE SCREWS WERE BROKEN BILATERALLY AT S1. THE SURGEON SAID THE PATIENT HAD SUFFERED A FALL AT SOME POINT AND COMPLAINED OF PAIN. HE HAD AN X-RAY AND MRI COMPLETED AND SAW THE SCREWS WERE BROKEN. HE WAS ABLE TO RETRIEVE BOTH BROKEN SCREW SHAFTS OUT OF S1 AND REPLACED BOTH. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SET SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), UNKNOWN ROD (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), LAMINA/PEDICLE/PROCESS HOOKS(PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS IS REPORT 02 OF 02 OF (B)(4).

  Patient problems: Pain

  MAUDE report 9744800 ↗
• InjuryFeb 24, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, A REVISION SURGERY WAS PERFORMED TO A L5-S1 (TLIF) WITH SCREWS FROM L4-S2. THE PATIENT HAD L5-S1 7X40 MM SCREWS, THE SCREWS WERE BROKEN BILATERALLY AT S1. THE SURGEON SAID THE PATIENT HAD SUFFERED A FALL AT SOME POINT AND COMPLAINED OF PAIN. HE HAD AN X-RAY AND MRI COMPLETED AND SAW THE SCREWS WERE BROKEN. HE WAS ABLE TO RETRIEVE BOTH BROKEN SCREW SHAFTS OUT OF S1 AND REPLACED BOTH. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SET SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), UNKNOWN ROD (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), LAMINA/PEDICLE/PROCESS HOOKS(PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS IS REPORT 01 OF 02 OF (B)(4).

  Patient problems: Pain

  MAUDE report 9744784 ↗
• InjuryJan 3, 2019Break; Break

  IT WAS REPORTED THAT UPON CASE FOR REMOVAL OF UNILATERAL HARDWARE INSTRUMENTATION AT L2-3 AND LAMINECTOMY AR L1-2, THE SURGEON DISCOVERED THE L3 SCREW WAS SHEERED OFF AT THE MEETING OF THE SADDLE/ HEAD OF SCREW AND PROXIMAL END OF THE SCREW SHAFT. THE SCREW SHAFT HAD TO BE LEFT IN THE PATIENT.

  Patient problems: No Code Available

  MAUDE report 8212800 ↗
• InjuryAug 13, 2018Break; Break

  BROKEN PEDICLE SCREW - INCOMPLETE L5/S1 FUSION. PATIENT CONSEQUENCE?: NO IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT?: YES.

  Patient problems: Not Applicable; Spinal Column Injury

  MAUDE report 7778416 ↗
• InjuryMay 22, 2018Break; Break

  IMPORTANT: THIS COMPLAINT WAS INITIALLY HANDED IN ON (B)(6) 2018 VIA SMARTPHONE. HOWEVER, COMPLAINT CAN NOT BE FOUND. HENCE, AN ERROR WHILE UPLOADING THE COMPLAINT OCCURED. FEMALE PATIENT HAD PRIMARY SPONDYLODESIS SURGERY FROM L4-S1 ON (B)(6) 2016. TWO DAYS POST INITIAL SURGERY, THE SURGEON NOTIVED ONE LOOSE INNIE AND INNIE WAS REPLACED. APP. 1.5 YEARS AFTER INITIAL SURGERY, PATIENT NOTICED AND CLAIMED A SQUEAKING OR STRANGE SOUND COMING FROM HER BACK OR THE IMPLANTS, RESPECTIVELY. PATIENT HAD REVISION SURGERY ON (B)(6) 2018. DURING THIS SURGERY, THE SURGEON NOTICED THAT BOTH S1 SCREWS (EXPEDIUM 7X40 MM 179712740) WERE BROKEN AT THE HEAD-SHAFT INTERFACE. ALL INNIES, RODS AND BROKEN SCREW HEAD WERE REMOVED, WHILE THE S1 SCREW SHAFTS WERE LEFT IN THE PEDICLES. AT THE TIME OF REVISION SURGERY, THE VERTEBRAE OF L5 AND S1 WERE FUSED. THEREFORE, THE SURGEON DECIDED TO SHORTEN THE ROD SCREW CONSTRUCT WITH 4 NEW INNIES AND 2 NEW SHORTER RODS FROM L4 TO L5. AT THE REQUEST OF THE PATIENT, THE BROKEN IMPLANTS WERE HANDED TO THE PATIENT. FOR THIS REASON, THE INVOLVED IMPLANTS CANNOT BE RETURNED. THE LOT NUMBERS OF THE IMPLANTS WILL BE PROVIDED AS SOON AS THEY ARE AVAILABLE. PATIENT CONSEQUENCE

  Patient problems: Spinal Column Injury

  MAUDE report 7532694 ↗
• InjuryMay 22, 2018Break; Break

  IMPORTANT: THIS COMPLAINT WAS INITIALLY HANDED IN ON FEBRUARY 1ST, 2018 VIA SMARTPHONE. HOWEVER, COMPLAINT CAN NOT BE FOUND. HENCE, AN ERROR WHILE UPLOADING THE COMPLAINT OCCURED. FEMALE PATIENT HAD PRIMARY SPONDYLODESIS SURGERY FROM L4-S1 ON (B)(6) 2016. TWO DAYS POST INITIAL SURGERY, THE SURGEON NOTICED ONE LOOSE INNIE AND INNIE WAS REPLACED. APP. 1.5 YEARS AFTER INITIAL SURGERY, PATIENT NOTICED AND CLAIMED A SQUEAKING OR STRANGE SOUND COMING FROM HER BACK OR THE IMPLANTS, RESPECTIVELY. PATIENT HAD REVISION SURGERY ON (B)(6) 2018. DURING THIS SURGERY, THE SURGEON NOTICED THAT BOTH S1 SCREWS (EXPEDIUM 7X40 MM 179712740) WERE BROKEN AT THE HEAD-SHAFT INTERFACE. ALL INNIES, RODS AND BROKEN SCREW HEAD WERE REMOVED, WHILE THE S1 SCREW SHAFTS WERE LEFT IN THE PEDICLES. AT THE TIME OF REVISION SURGERY, THE VERTEBRAE OF L5 AND S1 WERE FUSED. THEREFORE, THE SURGEON DECIDED TO SHORTEN THE ROD SCREW CONSTRUCT WITH 4 NEW INNIES AND 2 NEW SHORTER RODS FROM L4 TO L5. AT THE REQUEST OF THE PATIENT, THE BROKEN IMPLANTS WERE HANDED TO THE PATIENT. FOR THIS REASON, THE INVOLVED IMPLANTS CANNOT BE RETURNED. THE LOT NUMBERS OF THE IMPLANTS WILL BE PROVIDED AS SOON AS THEY ARE AVAILABLE. PATIENT CONS

  Patient problems: Spinal Column Injury

  MAUDE report 7532679 ↗
• InjuryNov 8, 2017Break; Break

  REVISION OF S1 LEFT.. FOR BROKEN SCREW... WHEN THE SURGEON WENT TO REMOVE THE SCREW, THE TIP BROKE PART OF THE SHANK IS STILL IN PATIENT COULD NOT RETRIEVE, PLACED A NEW SCREW IN S2. SURGEON THINKS ORIGINAL SURGERY WAS DONE IN 2014.

  Patient problems: Device Embedded In Tissue or Plaque; Failure of Implant; Injury

  MAUDE report 7009075 ↗
• InjuryOct 18, 2017Break; Break

  THIS WAS A REVISION SURGERY DUE TO A RE DECO AND SCREW BREAKAGE. CUSTOMER KINDLY ASKS US TO INVESTIGATE WHY THE SCREW BROKE. SCREW BREAKAGE S1 - PREVIOUS SURGERY WAS ON (B)(6).

  Patient problems: Failure of Implant

  MAUDE report 6958653 ↗
• MalfunctionOct 10, 2017Break; Break

  WHILE PERFORMING AN EXTENSION OF AN EXISTING SPONDYLODESIS, THE SCREW HEAD OF AN ALREADY IMPLANTED SCREW IN S1 (LEFT) BROKE AFTER LOOSENING THE INNIE AND ROD AND RETRACTING THE SOFT TISSUE AT THE IMPLANT LOCATION. THIS SCREW WAS IMPLANTED APP. 2 YEARS AGO. IT IS NOT CLEAR OR UNKNOWN WHETHER THE SCREW HEAD WAS ALREADY PARTIALLY BROKEN BEFORE EXTENSION SURGERY. IT IS THEREFORE BELIEVED THAT THE EVENT OCCURRED PERIOPERATIVE. SINCE THE PARTICULAR VERTEBRAL BODIES L5-S1 SEEMED TO BE FUSED, NO FURTHER ACTIONS WERE TAKEN, THE SCREW SHAFT WAS LEFT IN S1 AND THE SPONDY EXTENSION WAS PERFORMED AS PLANNED.

  Patient problems: Device Embedded In Tissue or Plaque; Failure of Implant

  MAUDE report 6935184 ↗
• InjurySep 13, 2017Break; Break

  BREAKAGE. SURGEON DID POSTERIOR LUMBAR DECOMPRESSION AND FUSION OPERATION ON (B)(6) 2016. HOWEVER, HE FOUND PAIN 2 MONTHS AGO. AND THEN HE WENT TO HOSPITAL ON (B)(6) 2017 TO HAVE A CHECK, IT FOUND THE SCREW BROKE. THE REVISION OPERATION WAS TAKEN ON (B)(6) 2017.

  Patient problems: Failure of Implant; Injury

  MAUDE report 6862776 ↗