EXPEDIUM VERSE 199723640Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10705034403090), received between Aug 28, 2017 and Dec 6, 2022 — classified as 8 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryDec 6, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT PATIENT WAS REQUIRING A L4/5 SPINAL FUSION REVISION FROM THE PRIMARY SURGERY PERFORMED IN 2000. THE LEFT L5 SCREW SHAFT HAD BROKEN INSITU. THE PATIENT HAD NOT SUCCESSFULLY FUSED, THE SURGEON CONSIDERED MANY OTHER CONTRIBUTING FACTORS, YET NOTED THAT THE INSTRUMENTATION WAS NOT THE ISSUE AND DID NOT FACTOR INTO THE SUCCESS OF THIS CASE. PATIENT STATUS/ OUTCOME / CONSEQUENCES :YES PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? BROKEN SCREW REQUIRING REVISION. THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE FEN SCR 6.0X40 THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 15923333 ↗
• InjuryMar 24, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PATIENT HAD A BROKEN SCREW IN HER RIGHT L5 PEDICLE. PATIENT STATUS/ OUTCOME / CONSEQUENCES? YES, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? PATIENT DEVELOPED A FACET CYST, POTENTIALLY DUE TO THE NON-UNION AND BROKEN SCREW., WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: YES, IF YES, DESCRIBE. REVISION AND REMOVAL OF IMPLANTS. THIS COMPLAINT INVOLVES ONE (1) DEVICE 5.5 EXP VERSE FEN SCR 6.0X40. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Cyst(s); Nonunion/Delayed-union Bone Fracture

  MAUDE report 13872568 ↗
• MalfunctionAug 18, 2021Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 THAT THE INSERTER COULD NOT BE ENTERED CORRECTLY INTO THE CORRECTION KEY AND SLIPPED DURING THE FINAL TIGHTENING. THIS DAMAGED THE THREAD OF THE SCREW HEAD. THERE WAS A SURGICAL DELAY OF 30 MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH REPLACEMENT SCREW AND SET SCREWS. THIS REPORT IS FOR ONE (1) EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 6.0 X 40MM. THIS IS REPORT 15 OF 15 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12335906 ↗
• InjuryNov 6, 2020Device Slipped; Device Slipped

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE IMPLANTS FROM A PREVIOUS POSTERIOR LUMBAR INTERBODY FUSION (PLIF) SURGERY PERFORMED ON (B)(6) 2020 WERE REMOVED ON (B)(6) 2020 DUE TO SUBSIDENCE OF THE CAGE AND LOOSENING OF THE SCREWS. L4-PLEVIS REVISION PROCEDURE WAS COMPLETED ON ON (B)(6) 2020. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE FEN SCR 6.0X40. THIS IS REPORT 9 OF 10 FOR COMPLAINT (B)(4). ADDITIONAL DEVICES ARE REPORTED UNDER RELATED COMPLAINT (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10805170 ↗
• InjuryNov 6, 2020Device Slipped; Device Slipped

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE IMPLANTS FROM A PREVIOUS POSTERIOR LUMBAR INTERBODY FUSION (PLIF) SURGERY PERFORMED ON (B)(6) 2020 WERE REMOVED ON (B)(6) 2020 DUE TO SUBSIDENCE OF THE CAGE AND LOOSENING OF THE SCREWS. L4-PLEVIS REVISION PROCEDURE WAS COMPLETED ON ON (B)(6) 2020. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE FEN SCR 6.0X40. THIS IS REPORT 2 OF 10 FOR COMPLAINT (B)(4). ADDITIONAL DEVICES ARE REPORTED UNDER RELATED COMPLAINT (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10804982 ↗
• InjuryAug 25, 2020Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON AN UNKNOWN DATE. DURING THE SURGERY, A BROKEN SCREW WAS REMOVED, ALONG WITH ANOTHER SCREW, BOTH RODS, AND BOTH SET SCREWS. THE BROKEN SCREW WAS DISCOVERED ON PREOPERATIVE IMAGING. THIS REPORT IS FOR A 5.5 EXPEDIUM VERSE FENESTRATED SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10448684 ↗
• InjuryJun 30, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED A SET SCREW WAS WASHED OUT OF THE WOUND ON (B)(6) 2020 FOR AN INFECTION. THE SET SCREW WAS PLACED BACK ON AND THEN FINAL TIGHTENING WAS COMPLETED. THE PRIMARY SURGERY WAS FOR A L4/L5 POSTERIOR LUMBAR INTERBODY FUSION (PLIF) ON (B)(6) 2020. CONCOMITANT DEVICE REPORTED: TORQUE WRENCH HANDLE 80IN-LB (PART#: 299704320, LOT#: UNKNOWN, QUANTITY 2). VERSE X25 INSERTER/TIGHTENER (PART#: 299704230, LOT#: UNKNOWN, QUANTITY 4). THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 10211424 ↗
• MalfunctionApr 9, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT ALL FOUR INSTRUMENT PARTS HAVE SEIZED TOGETHER DUE TO MALFUNCTION. IT WAS FOUND DURING THE LOAN KIT INSPECTION. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES FOUR (4) DEVICE. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9943412 ↗
• InjuryJan 8, 2020Crack; Crack

  IT WAS FURTHER REPORTED THAT HARDWARE REMOVAL PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY ISSUES OR DIFFICULTY.

  Patient problems: No Code Available

  MAUDE report 9565134 ↗
• MalfunctionDec 12, 2017Break; Break

  WHEN PLACING THE IMPLANTS AND THEIR RESPECTIVE LOCKING SCREWS, AND WHEN APPLYING FORCE, THE LOCKING SCREWS JUMP, PRODUCING DAMAGE TO THE IMPLANTS, WHICH MUST BE REPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7108175 ↗
• InjuryAug 28, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  GRADE 4 SPONDYLOLITHESIS CORRECTION L5/S1. A SPONDYLOLITHESIS CORRECTION THAT WAS PERFORMED ON THE (B)(6) 2017 WAS REVISED FOR CONSTRUCT FAILURE. THE PATIENT HAD A VERSE SCREW 6 X 40 MM FRACTURE THROUGH THE VERTEBRAL BODY OF S1 ON THE LEFT SIDE. THE RIGHT SIDE L5 SCREW HAD ALSO DISCONNECTED WITH THE 35 MM VIPER ROD, SET SCREW WAS STILL IN THE SCREW HEAD. ON REMOVAL OF THE CONSTRUCT THE SURGEON NOTICED THAT THE L5 LEFT SIDED SET SCREW APPEARED TO BE LOOSE. THE SURGEON REMOVED ALL SCREWS, RODS, SET SCREWS (6 X 40 MM AT S1 AND 6 X 35 MM L5) AND MEDTRONIC R90 IMPLANTS (PLIF CAGE).THEN REPLACED THE SCREWS AT L5 WITH X 27 X 35 MM SCREWS AND X 17 X 40 MM AT S1 LEFT SIDE AND X17 X 35 AT S1 RIGHT SIDE. HE ALSO PLACE SAI (SACRAL ALAR ILIAC SCREWS) 8 X 80 MM SCREWS IN THE PELVIS. HE THEN REPLACED THE RODS (COCR) AND REDUCED L5 BACK INTO POSITION AND REPLACED MEDTRONIC R90 INTERBODY CAGES, COMPRESSED AT L5/S1 AND FINAL TIGHTENED. THE REVISION SURGERY WAS UNEVENTFUL.

  Patient problems: Failure of Implant

  MAUDE report 6824812 ↗