EXPEDIUM VERSE 199723645Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10705034403083), received between Dec 11, 2017 and Jan 8, 2024 — classified as 19 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (17 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 21 most recent of 21 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

  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, INSTABILITY, NEUROCOMPRESSION, SPINAL IMBALANCE. COMPLICATION TIME/INTERVENTION. REPEAT SURGERY. THIS REPORT IS FOR AN EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 6.0 X 45MM. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: Joint Laxity; Nerve Damage; Osteolysis

  MAUDE report 18464646 ↗
• 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: NEUROCOMPRESSION, COMPLICATION TIME/INTERVENTION, REPEAT SURGERY. THIS REPORT INVOLVES ONE EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 6.0 X 45MM. THIS IS REPORT 3 OF 6 FOR (B)(4).

  Patient problems: Nerve Damage

  MAUDE report 18462961 ↗
• 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: HARDWARE REMOVAL, COMPLICATION TIME/INTERVENTION, REPEAT SURGERY. THIS IS FOR DEPUY SYNTHES SPINE EXPEDIUM VERSE FENESTRATED PRODUCTS. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18451511 ↗
• InjuryNov 21, 2023Break; Entrapment of Device; Break; Entrapment of Device

  REVISION SURGERY WAS COMPLETED SUCCESSFULLY. IT WAS FURTHER REPORTED BROKEN FRAGMENTS REMAINED IN THE PATIENT. NO ADDITIONAL INTERVENTION WAS USED TO REMOVE THE FRAGMENTS. PATIENT STATUS IS UNKNOWN. (B)(4) IS LINKED TO (B)(4) TO CAPTURE ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: Foreign Body In Patient; Unspecified Infection

  MAUDE report 18182358 ↗
• InjuryNov 21, 2023Break; Entrapment of Device; Break; Entrapment of Device

  REVISION SURGERY WAS COMPLETED SUCCESSFULLY. IT WAS FURTHER REPORTED BROKEN FRAGMENTS REMAINED IN THE PATIENT. NO ADDITIONAL INTERVENTION WAS USED TO REMOVE THE FRAGMENTS. PATIENT STATUS IS UNKNOWN. (B)(4) IS LINKED TO (B)(4) TO CAPTURE ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: Foreign Body In Patient; Unspecified Infection

  MAUDE report 18181067 ↗
• InjuryMay 22, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT SURGERY TO IMPLANT THE L45 INTERBODY CAGE (CONCORDE TITANIUM OBLIQUE) AT L45S1. NO CAGE WAS PLACED AT L5S1. A REVISION WAS PERFORMED ON (B)(6) 2023 BECAUSE ONE OF THE EXPEDIUM VERSE ADVANCED SCREWS HAD BROKEN. NO SPECIFIC EVENT CAUSED THE FRACTURE, BUT IT SEEMED AS THE THE PATIENT HAD AN ASSOCIATED BONY FRACTURE AS WELL. THE REVISION INVOLVED THE REPLACEMENT OF THE SCREW WITH A 7/50MM VERSION, AND ALL WENT FINE. THE PATIENT IS DOING WELL AFTER THE CASE. DURING THE SURGERY, ONE OF THE INSTRUMENTS STRIPPED. NOT MUCH TIME WAS LOST, AS ANOTHER WAS AVAILABLE TO BE USED. THE OUTCOME WAS FINE. THIS REPORT INVOLVES ONE EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 6.0 X 45MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Bone Fracture(s); Failure of Implant

  MAUDE report 16972955 ↗
• InjuryMar 9, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN BELGIUM AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, AN EXTRACTION OF BROKEN SCREWS WAS PERFORMED. A CT AND RX SCAN WAS PERFORMED AFTER PATIENT COMPLAINTS, AND IT WAS NOTED THAT THE SCREW WAS BROKEN OFF JUST AT THE HEAD LEVEL. THE SCREW WAS INITIALLY PLACED ON LEVEL L2 (RIGHT) WHEN FIXATING A FRACTURE ON DISC LEVEL L1 AROUND FOUR YEARS AGO. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 6.0 X 45MM. THIS IS REPORT 1 OF 1 FOR (B)(4) .

  Patient problems: Failure of Implant

  MAUDE report 16512441 ↗
• InjuryFeb 21, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THERE WAS SCREW BREAKAGE OF VIPER PRIME SCREW, REVISION SURGERY IS NEEDED IN ORDER TO REMOVE THE BROKEN SCREW AND REPLACE IT. THE REVISION SURGERY TOOK PLACE ON (B)(6) 2023. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE FEN SCR 6.0X45. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 16409177 ↗
• InjuryNov 7, 2021Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN BELGIUM. IT WAS NOTED THAT THERE IS NO CURRENT PLAN FOR ANOTHER PROCEDURE TO REMOVE THE REMAINING FRAGMENTS FROM THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 12759852 ↗
• MalfunctionOct 19, 2021Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 DURING A POSTERIOR LUMBAR INTERBODY FUSION, FOUR (4) CAPS AND ONE (1) SCREW WERE BROKEN OFF AND ALL THE BROKEN PARTS WERE REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT OR SURGICAL DELAY. THIS REPORT IS FOR ONE (1) EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 6.0 X 45MM. THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12658071 ↗
• InjuryNov 17, 2020Break; Break

  ADDITIONAL EVENT INFORMATION: ALL FRAGMENTS WERE RETRIEVED EXCEPT FOR THOSE DEEP IN BONE.

  Patient problems: Failure of Implant; No Code Available; Pain

  MAUDE report 10855821 ↗
• InjuryNov 17, 2020Break; Break

  ADDITIONAL EVENT INFORMATION ALL FRAGMENTS WERE RETRIEVED EXCEPT FOR THOSE DEEP IN BONE.

  Patient problems: Failure of Implant; No Code Available; Pain

  MAUDE report 10855672 ↗
• MalfunctionNov 12, 2020Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED A REVISION PROCEDURE OCCURRED ON AN UNKNOWN; THE EXPLANTED DEVICES ARE NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER.

  Patient problems: Failure of Implant; Foreign Body In Patient; Osteolysis

  MAUDE report 10831636 ↗
• InjurySep 24, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE VERSE ADVANCED SCREWS BROKE IN THE VERTEBRAL BODY POST-OPERATION. THERE IS NO FURTHER INFORMATION AVAILABLE. CONCOMITANT DEVICE REPORTED: VERSE CORRECTION KEY (PART# 199721000 , LOT# 206919, QUANTITY 1); VERSE CORRECTION KEY (PART# 199721000 , LOT# 196158, QUANTITY 1); VERSE CORRECTION KEY (PART# 199721000 , LOT# 190651, QUANTITY 1); VERSE CORRECTION KEY (PART# 199721000 , LOT# 190159, QUANTITY 1); 5.5 EXP VERSE FEN SCR 6.0X45 (PART# 199723645, LOT# 155845, QUANTITY 1); 5.5 EXP VERSE FEN SCR 6.0X45 (PART# 199723645, LOT# 184191, QUANTITY 1); 5.5 EXP VERSE FEN SCR 6.0X45 (PART# 199723645, LOT# 175103, QUANTITY 1); 5.5 EXP VERSE FEN SCR 6.0X45 (PART# 199723645, LOT# 184192, QUANTITY 1). THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE FEN SCR 6.0X45. THIS IS REPORT 1 OF 8 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available; Spinal Column Injury

  MAUDE report 10580940 ↗
• InjurySep 15, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THAT A PATIENT PRESENTED POST-OP WITH TWO (2) FRACTURED BILATERAL EXPEDIUM VERSE SIZE 6MM SCREWS. THE INITIAL IMPLANT PROCEDURE WAS PERFORMED ON (B)(6) 2018. A REVISION SURGERY HAS BEEN SCHEDULED FOR AN UNKNOWN DATE AND THE BROKEN SCREWS WILL BE REPLACED. CONCOMITANT DEVICE REPORTED: SETSCREW (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN), RODS (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN), EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 6.0 X 45MM (PART NUMBER 199723645, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 6.0 X 45MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10535637 ↗
• InjurySep 15, 2020Break; Break

  IT WAS FURTHER REPORTED THE REVISION PROCEDURE OCCURRED ON (B)(6), 2020.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10535602 ↗
• InjuryMay 26, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT INITIALLY ON (B)(6) 2016 THE PATIENT UNDERWENT A LUMBAR SPINE FUSION PROCEDURE. PATIENT WAS REVISED ON (B)(6) 2019 FOR AN UNKNOWN REASON. DURING THE REVISION PROCEDURE, THE BROKEN SCREW WAS NOTICED AFTER REMOVING THE ROD AND SET SCREW. NO DRIVER WAS ON THE BROKEN SCREW AT THE TIME IT WAS DISCOVERED. SURGEON REMOVED AND EXTENDED THE CONSTRUCT WITH COMPETITOR'S SYSTEM. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: 5.5 EXP VERSE UNITIZED SET SCR (PART# 199721001, LOT# UNKNOWN, QUANTITY 4); MMSI ROD PREBENT, 5.5 X45MM, T (PART# 179772045, LOT# UNKNOWN, QUANTITY 2); 5.5 EXP VERSE FEN SCR 6.0X45 (PART# 199723645, LOT# UNKNOWN, QUANTITY 3). THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE FEN SCR 6.0X45. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10089410 ↗
• InjuryMay 26, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT INITIALLY ON (B)(6) 2019 THE PATIENT UNDERWENT A L3/5 POSTEROLATERAL INTERBODY FUSION PROCEDURE. PATIENT WAS RECENTLY SEEN BY SURGEON FOR BACK PAIN. POSTOPERATIVELY A BROKEN SCREW WAS IDENTIFIED IN THE CONSTRUCT. THE BROKEN SCREW IS STILL IN SITU AS THERE HAS BEEN NO PLAN FOR REVISION SURGERY AT THIS POINT IN TIME. SURGEON MENTIONED THAT BACK PAIN MAY NOT BE DIRECTLY RELATED TO THE BROKEN SCREW. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: CONCORDE BUL PAR 9X11X23 (PART# 187823111, LOT# UNKNOWN, QUANTITY 4); 5.5 EXP VERSE UNITIZED SET SCR (PART# 199721001, LOT# UNKNOWN, QUANTITY 5); 5.5 EXP VERSE FEN SCR 6.0X45 (PART# 199723645, LOT# UNKNOWN, QUANTITY 3); 5.5 EXP VERSE FEN SCR 6.0X40 (PART# 199723640, LOT# UNKNOWN, QUANTITY 1); MMSI ROD PREBENT, 5.5 X65MM, T (PART# 179772065, LOT# UNKNOWN, QUANTITY 2). THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE FEN SCR 6.0X45. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10089354 ↗
• InjuryDec 20, 2018Break; Break

  IT WAS REPORTED THAT THE VERSE ADVANCED SCREWS BROKE POST. OP IN THE VERTEBRAL BODY. PATIENT CONSEQUENCE? :UNKNOWN.

  Patient problems: No Code Available; No Consequences Or Impact To Patient; Spinal Column Injury

  MAUDE report 8185812 ↗
• InjuryDec 20, 2018Break; Break

  IT WAS REPORTED THAT THE VERSE ADVANCED SCREWS BROKE POST. OP IN THE VERTEBRAL BODY PATIENT CONSEQUENCE? :UNKNOWN.

  Patient problems: No Code Available; No Consequences Or Impact To Patient; Spinal Column Injury

  MAUDE report 8185781 ↗
• InjuryDec 11, 2017No Apparent Adverse Event; No Apparent Adverse Event

  L5/S1 PLIF, (B)(6), (B)(6) HOSPITAL, (B)(6) 2017. PRIMARY IMPLANT DATE: (B)(6) 2017. CORRECTION OF MISPLACED S1 PEDICLE SCREW (B)(6) 2017 RIGHT S1SCREW WAS PLACED TOO MEDIALLY AND BREACHED THE PEDICLE WALL AND WAS FOUND ON POST OP IMAGING TO BE IN THE CANAL. SURGEON ERROR. FEMALE PATIENT ID: (B)(6).

  Patient problems: Spinal Column Injury

  MAUDE report 7105426 ↗