EXPEDIUM VERSE 199723750Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10705034402901), received between Oct 30, 2017 and Jan 8, 2024 — classified as 5 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 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

  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: OTHER HEMATOMA, ADJACENT SEGMENT PATHOLOGY, INSTABILITY COMPLICATION TIME/INTERVENTION POSTOPERATIVE (BEFORE DISCHARGE), REPEAT SURGERY THIS IS FOR DEPUY SYNTHES SPINE EXPEDIUM /OTHER ,EXPEDIUM VERSE FENESTRATED ,MOSS MIAMI SI /OTHER AND VIPER CFX FENESTRATED PRODUCTS THIS IS REPORT 3 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Hematoma; Joint Laxity; Osteolysis

  MAUDE report 18466287 ↗
• 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 7.0 X 50MM. THIS IS REPORT 6 OF 6 FOR (B)(4).

  Patient problems: Nerve Damage

  MAUDE report 18462955 ↗
• 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: NEURO COMPRESSION, NON-UNION COMPLICATION TIME/INTERVENTION REPEAT SURGERY 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: Nerve Damage; Nonunion/Delayed-union Bone Fracture

  MAUDE report 18447538 ↗
• MalfunctionJan 4, 2022Device Slipped; Device Slipped

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 DURING LOANER SET INSPECTION AT A THIRD PARTY LOGISTICS CENTER, THE EXPEDIUM FENESTRATED SCREW WAS FOUND TO BE LOOSE. THERE WAS A GAP IN BETWEEN THE SCREW CAP AND SCREW HEAD. THERE WAS NO PATIENT INVOLVEMENT. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 7.0 X 50MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13151803 ↗
• MalfunctionAug 11, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 A PATIENT NEEDED A REVISION OPERATION. BEFORE THE SURGERY THE SCREW HEADS WERE CHECKED AND COULD NOT BE MOVED ANYMORE TO ADJUST THE HEAD. THE POLYAXIAL HEADS HAVE A POLY DRAG FEATURE, WHICH MAKES THE HEADS UNABLE TO BE MOVED INTO ANOTHER POSITION ONCE LOCKED. HOWEVER, THE SURGEON USES THE CORRECTION KEY TABS AND WANTED TO PROFIT FROM THE DI FEATURE, WHICH IS NOT POSSIBLE ANYMORE. THOSE SCREWS WERE REPLACED WITH EXPEDIUM SYSTEM. CONCOMITANT DEVICES: UNKNOWN SCREWDRIVER (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN), UNKNOWN RODS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN), UNKNOWN LOCKING/ SET SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 7.0 X 50MM. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10393072 ↗
• MalfunctionAug 11, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 A PATIENT NEEDED A REVISION OPERATION. BEFORE THE SURGERY THE SCREW HEADS WERE CHECKED AND COULD NOT BE MOVED ANYMORE TO ADJUST THE HEAD. THE POLYAXIAL HEADS HAVE A POLY DRAG FEATURE, WHICH MAKES THE HEADS UNABLE TO BE MOVED INTO ANOTHER POSITION ONCE LOCKED. HOWEVER, THE SURGEON USES THE CORRECTION KEY TABS AND WANTED TO PROFIT FROM THE DI FEATURE, WHICH IS NOT POSSIBLE ANYMORE. THOSE SCREWS WERE REPLACED WITH EXPEDIUM SYSTEM. CONCOMITANT DEVICES: UNKNOWN SCREWDRIVER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN); UNKNOWN RODS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN); UNKNOWN LOCKING/SET SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 7.0 X 50MM. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10393060 ↗
• MalfunctionAug 11, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 A PATIENT NEEDED A REVISION OPERATION. BEFORE THE SURGERY THE SCREW HEADS WERE CHECKED AND COULD NOT BE MOVED ANYMORE TO ADJUST THE HEAD. THE POLYAXIAL HEADS HAVE A POLY DRAG FEATURE, WHICH MAKES THE HEADS UNABLE TO BE MOVED INTO ANOTHER POSITION ONCE LOCKED. HOWEVER, THE SURGEON USES THE CORRECTION KEY TABS AND WANTED TO PROFIT FROM THE DI FEATURE, WHICH IS NOT POSSIBLE ANYMORE. THOSE SCREWS WERE REPLACED WITH EXPEDIUM SYSTEM. CONCOMITANT DEVICES: UNKNOWN SCREWDRIVER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN); UNKNOWN RODS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN); UNKNOWN LOCKING/SET SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 7.0 X 50MM. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10393048 ↗
• MalfunctionJun 8, 2020Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT HAD A SURGERY AND DURING THE SURGERY WHEN INSERTING THE CORRECTION KEY AND A UNITIZED SET SCREW IN THE EXTENDED TAP OF A 7X50 MM EXP VERSE CFX SCREW, BOTH INNIES BROKE. THAT MEANS A RING/CHIP BROKE OFF. THE PROBLEM OCCURRED IN THE LOWER LEVEL OF THE TAPS. AFTER THAT THE FIXATION WITH THE CORRECTION KEY AND THE UNITIZED SET SCREW WAS NOT POSSIBLE ANYMORE, AND THE SURGEON HAD TO CHANGE THE SCREW. ALL GENERATED FRAGMENTS WERE REMOVED WITHOUT ANY ADDITIONAL INTERVENTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 30 MINUTES DELAY. THERE WERE NO PATIENT CONSEQUENCES. CONCOMITANT DEVICE REPORTED: UNKNOWN KEY INSERTER/TIGHTENER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10129963 ↗
• MalfunctionJan 8, 2020Break; Break

  TWO CORRECTION KEYS OF EXPEDIUM VERSE BROKE APART WHILE TIGHTENING WITH TORQUE LIMITING HANDLE. CORRECTION KEYS AND SCREW WERE REPLACED WITH A NEW CORRECTION KEY AND NEW SCREW. DELAY OF SURGERY WAS ABOUT 15MIN. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT?: UNKNOWN. WAS PROCEDURE SUCCESSFULLY COMPLETED?: UNKNOWN. WERE FRAGMENTS GENERATED?: UNKNOWN. IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION?: UNKNOWN. PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN. IP-00762218 DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. IP-00762219 DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE. CONCOMITANT DEVICE REPORTED: UNKNOWN TORQUE LIMITING HANDLE (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY: 1). THIS COMPLAINT INVOLVES THREE (3) DEVICES.

  Patient problems: Not Applicable

  MAUDE report 9563547 ↗
• MalfunctionNov 27, 2019Break; Break

  A FEMALE PATIENT, BORN (B)(6), WAS TREATED TODAY ((B)(6) 2019) WITH THE EXPEDIUM VERSE ADAVANCED SET (ORTHOKIT, SEE SCREENSHOT OF RESERVATION) AT L3-L4. WHEN THE CORRECTION CAP WAS INSERTED, IT WAS TILTED IN THE LONG HEAD OF THE EXPEDIUM VERSE ADVANCED SCREW SO MUCH THAT THE LONG THREAD OF TWO SCREWS WAS DEFECTIVE AND A TOTAL OF 6 CORRECTION CAPS WERE DEFECTIVE. AT THE FINAL TIGHTENING WITH TORQUE OF THE INNER ADJUSTING SCREW IN ONE SITUATION THE INNER ADJUSTING SCREW WAS SO DEFECTIVE THAT IT BROKE. SURGICAL DELAY ABOUT 1 HOUR, PROCEDURE WAS COMPLETED WITH MODULAR END CAPS AFTER THEY CHANGED TWO SCREWS.

  Patient problems: Not Applicable

  MAUDE report 9383423 ↗
• InjuryOct 30, 2017Loose or Intermittent Connection; Loose or Intermittent Connection

  L4/S1 POSTERIOR STABILISATION. PATIENT PRESENTED FOR ROUTINE 3 MONTH POST OP. FOLLOW UP, COMPLAINING OF BACK PAIN. UPON INVESTIGATION, THE IMAGING REVEALED THAT THE CONSTRUCT RODS HAD MIGRATED CRANIALLY, AND ARE COMPLETELY OUT OF THE S1 SCREWS. THIS IS EVIDENT WHEN COMPARING THE CONSTRUCT TO THE IMAGE TAKEN IMMEDIATELY POST OP.

  Patient problems: Failure of Implant

  MAUDE report 6988546 ↗
• InjuryOct 30, 2017Loose or Intermittent Connection; Loose or Intermittent Connection

  L4/S1 POSTERIOR STABILISATION. PATIENT PRESENTED FOR ROUTINE 3 MONTH POST OP. FOLLOW UP, COMPLAINING OF BACK PAIN. UPON INVESTIGATION, THE IMAGING REVEALED THAT THE CONSTRUCT RODS HAD MIGRATED CRANIALLY, AND ARE COMPLETELY OUT OF THE S1 SCREWS. THIS IS EVIDENT WHEN COMPARING THE CONSTRUCT TO THE IMAGE TAKEN IMMEDIATELY POST OP.

  Patient problems: Failure of Implant

  MAUDE report 6988484 ↗