EXPEDIUM VERSE 199723750SRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10705034444499), received between Jan 5, 2021 and Jun 3, 2024 — classified as 11 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJun 3, 2024Break; Break

  IT WAS REPORTED THAT THIS WAS A POSTERIOR FUSION PERFORMED ON (B)(6) 2022. AFTER THE SURGERY ON (B)(6) 2024, THE SALES REP WAS INFORMED THAT THE ROD AND SCREW BROKE OFF. ON (B)(6) 2024, THE SECOND SURGERY WAS PERFORMED. BILATERAL RODS WERE REMOVED AND THE BROKEN SCREW HEADS WERE REMOVED. A VERSE FENESTRATED SCREW WAS INSERTED AT THE,9 AND L3,4 AND BONE CEMENT WAS INJECTED INTO ALL SCREWS. AFTER THE BONE CEMENT HARDENED, RODS WERE PLACED BILATERALLY. UNIVERSAL AND SFX CONNECTORS WERE USED, AND ADDITIONAL RODS WERE PLACED NEAR THE MIDLINE. THIS REPORT INVOLVES ONE (1) EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 7.0 X 50MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19449458 ↗
• MalfunctionApr 29, 2024Migration; Migration

  IT WAS REPORTED THAT THIS WAS AN UNKNOWN SURGERY PERFORMED ON (B)(6) 2024, WITH THE CEMENT IN QUESTION. THIS SURGERY WAS THE SECOND SURGERY, AND THERE WERE NO J&J PRODUCTS USED IN THE INITIAL SURGERY. TWO AND A HALF (2.5) MONTHS AFTER THE SURGERY, THE SCREW LOOSENING WAS CONFIRMED. A LARGE CLEAR ZONE HAD FORMED AROUND THE CEMENT MASS. THIS IS A CASE WHERE THE CEMENT IS NOT FIRMLY ENGAGED AND IN WHICH THE SCREW MAY BE REMOVED WITH CEMENT LUMPS STUCK AROUND IT. NO ADDITIONAL INFORMATION IS AVAILABLE. REMARKS: (B)(4) AND (B)(4) ARE INVOLVED WITH THE SAME EVENT. (B)(4) (SYNTHES SPINE): CEMENT (B)(4) (DEPUY SPINE): SCREW THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE FEN SCR 7.0X50 THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19209869 ↗
• 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. COMPLICATION TIME/INTERVENTION. REPEAT SURGERY. THIS REPORT INVOLVES ONE EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 7.0 X 50MM THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 18455659 ↗
• 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: IMPLANT MALPOSITION, COMPLICATION TIME/INTERVENTION, AND REPEAT SURGERY. THIS IS FOR DEPUY SYNTHES SPINE EXPEDIUM /OTHER, EXPEDIUM VERSE FENESTRATED AND MOSS MIAMI SI /OTHER PRODUCTS. THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18455571 ↗
• InjuryOct 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SALES REP WAS CONTACTED BY SURGEON¿S OFFICE STAFF ON (B)(6) 2023 REQUESTING THE METAL COMPOSITION FOR IMPLANTS USED ON A PATIENT . HE EMAILED SURGEON AND HIS STAFF DIRECTLY AFTER BEING CONTACTED. HE PROVIDED THEM WITH THE REQUESTED INFORMATION FOR EXPEDIUM AND METAL COMPOSITION BREAKDOWNS. THEY SAID THE PATIENT WAS EXPERIENCING SWELLING, REDNESS AND IRRITATION IN HIS ABDOMEN. POTENTIALLY MAY BE HAVING A REACTION TO THE IMPLANTS. HE WAS CONTACTED AGAIN BY SURGEON¿S OFFICE THIS AFTERNOON. THE PATIENT WAS REFERRED TO A DERMATOLOGIST AND SURGEON¿S OFFICE ASKED IF WE COULD PROVIDE "PATCH TEST KIT¿. THIS REPORT IS FOR ONE (1)5.5 EXP VERSE FEN SCR 7.0X50 THIS IS REPORT 9 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction; Swelling/ Edema

  MAUDE report 17940008 ↗
• InjuryOct 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SALES REP WAS CONTACTED BY SURGEON¿S OFFICE STAFF ON 9/27/2023 REQUESTING THE METAL COMPOSITION FOR IMPLANTS USED ON A PATIENT . HE EMAILED SURGEON AND HIS STAFF DIRECTLY AFTER BEING CONTACTED. HE PROVIDED THEM WITH THE REQUESTED INFORMATION FOR EXPEDIUM AND METAL COMPOSITION BREAKDOWNS. THEY SAID THE PATIENT WAS EXPERIENCING SWELLING, REDNESS AND IRRITATION IN HIS ABDOMEN. POTENTIALLY MAY BE HAVING A REACTION TO THE IMPLANTS. HE WAS CONTACTED AGAIN BY SURGEON¿S OFFICE THIS AFTERNOON. THE PATIENT WAS REFERRED TO A DERMATOLOGIST AND SURGEON¿S OFFICE ASKED IF WE COULD PROVIDE "PATCH TEST KIT¿. THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE FEN SCR 7.0X50. THIS IS REPORT 2 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction; Swelling/ Edema

  MAUDE report 17939941 ↗
• InjuryFeb 24, 2023Adverse 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 THIS WAS AN UNKNOWN SURGERY (L1 TO S2) FOR THE LUMBAR VERTEBRAL CANAL STENOSIS AND THE L4 FRACTURE ON (B)(6) 2022. THE SCREW WAS INSERTED INTO L1, AND 1 CC OF THE CEMENT WAS INJECTED ON EACH SIDE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. FOUR MONTHS LATER, L1 FRACTURE WAS CONFIRMED, AND A REVISION SURGERY WILL BE PERFORMED. ACCORDING TO THE SURGEON, THE PATIENT HAS VERY WEAK BONE QUALITY. THE SURGEON DOES NOT THINK THAT THE DEVICES WERE NOT THE CAUSE OF THE EVENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 7.0 X 50MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 16438573 ↗
• InjuryFeb 23, 2023Device Slipped; Device Slipped

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR FUSION ON (B)(6) 2022. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. ON (B)(6) 2022, A REVISION SURGERY WAS PERFORMED FOR AN UNKNOWN REASON. MESH CAGE WAS INSTALLED IN VCR AREA. IN (B)(6), THE MESH CAGE FELL INTO THE LOWER VERTEBRAL BODY AND BECAME UNSTABLE. THE IMAGE SHOWED THAT THE SCREWS WERE LOOSENED. THEREFORE, A SECOND REVISION SURGERY WAS PERFORMED. THE SPECIFIC DATE OF THE EVENT IS UNKNOWN, AS IT DEVELOPED GRADUALLY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 7.0 X 50MM. THIS REPORT IS RELATED TO (B)(4), WHICH REPORTS THE MESH CAGE. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 16432041 ↗
• InjuryFeb 23, 2023Device Slipped; Device Slipped

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR FUSION ON (B)(6) 2022. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. ON (B)(6) 2022, A REVISION SURGERY WAS PERFORMED FOR AN UNKNOWN REASON. MESH CAGE WAS INSTALLED IN VCR AREA. IN JANUARY, THE MESH CAGE FELL INTO THE LOWER VERTEBRAL BODY AND BECAME UNSTABLE. THE IMAGE SHOWED THAT THE SCREWS WERE LOOSENED. THEREFORE, A SECOND REVISION SURGERY WAS PERFORMED. THE SPECIFIC DATE OF THE EVENT IS UNKNOWN, AS IT DEVELOPED GRADUALLY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 7.0 X 50MM. THIS REPORT IS RELATED TO (B)(4), WHICH REPORTS THE MESH CAGE. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 16431946 ↗
• InjurySep 27, 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 PATIENT UNDERWENT THORACOLUMBAR POSTERIOR FUSION (TH9 TO L3) FOR A CENTRUM FRACTURE (L1) ON (B)(6) 2022. THE CEMENT AUGMENTATION WAS PERFORMED TO TH9 AND L3 WITH FENESTRATED SCREW AND CEMENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. ALTHOUGH INITIAL FUSION WAS STABLE, THE PATIENT COMPLAINED OF PAIN DURING REHABILITATION. NEW FRACTURE WAS CONFIRMED BY CT. FUTURE TREATMENT IS UNDECIDED. THE SURGEON COMMENTED THAT THE STRONG FUSION MAY HAVE CAUSED THE L3 TO BE OVERLOADED AND FRACTURED, ALTHOUGH THE PAIN WAS NOT DUE TO THE IMPLANT AND THE CEMENT. THIS REPORT IS FOR A 5.5 EXP VERSE FEN SCR 7.0X50. THIS IS REPORT 1 OF 1 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 15495011 ↗
• InjurySep 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED ON MAY 19, 2022, THE SURGEON REPORTED ABOUT THE ROD LOOSENING EXPEDIUM VERSE. IT WAS A RESTORATION OF NON-SPECIFIC CAUSE IN TWO PATIENTS. REVISION AND CONFIRMATION OF COLI INFECTION. THIS EXPLAINS THE SITUATION OF NON-FUSION AND ROD LOOSENING ACCORDING TO THE SURGEON. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1)5.5 EXP VERSE FEN SCR 7.0X50. THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 15403467 ↗
• MalfunctionDec 17, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021 DURING AN UNKNOWN PROCEDURE, ONE (1) FENESTRATED SCREW AND ONE (1) UNKNOWN SCREW WERE BROKEN. THE SCREWS WERE UNABLE TO BE LOCKED IN. THE SURGEON USED ANOTHER SCREW TO COMPLETE THE PROCEDURE. THERE WAS A SURGICAL DELAY OF FORTY-FIVE (45) MINUTES. THE PATIENT OUTCOME IS UNKNOWN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 7.0 X 50MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13026134 ↗
• InjuryJan 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT HAD L2-5 POSTERIOR LUMBAR FUSION ON (B)(6). PATIENT STARTED HAVING SOME PAIN IN (B)(6) 2020. SURGEON OBTAINED CT SCAN ON. (B)(6). RESULTS OF CT SCAN REVEALED POSSIBLE NON-UNION. SURGERY WAS SCHEDULED. NON-UNION WAS CONFIRMED IN THE CASE, THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS DOING WELL, WENT HOME THE NEXT DAY. THIS COMPLAINT INVOLVES (5) DEVICES. THIS REPORT IS FOR (1)5.5 EXP VERSE FEN SCR 7.0X50. THIS REPORT IS 1 OF 5 FOR (B)(4).

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

  MAUDE report 11118577 ↗