EXPEDIUM VERSE 199723740Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034402925), received between Oct 5, 2017 and Nov 6, 2020 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Slipped” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• 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 7.0X40. THIS IS REPORT 3 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 10805092 ↗
• 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 7.0X40. THIS IS REPORT 10 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 10805031 ↗
• InjuryFeb 12, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING A REVISION SURGERY 2 OF 4 VERSE INNIES WERE FOUND LOOSE BESIDE THE CONSTRUCT AND 4 VERSE SCREWS SEEMED LOOSE AS WELL. ALREADY IN THE REOP X-RAY THE INNIES SEEMED NOT TIGHTENED AND THE SCREWS LOOSE.

  Patient problems: No Code Available

  MAUDE report 8333479 ↗
• InjuryOct 5, 2017Torn Material; Torn Material

  L5/S1 SPONDYLOLITHESIS CORRECTION WITH L5/S1 TLIF AND PLF. PREVIOUS L5/S1 TLIF FOR SPONDYLOLITHESIS REDUCTION 28.8.2017. REDUCED WELL INITIALLY. PATIENT FELL AFTER DISCHARGE FROM HOSPITAL AND HAD L5 SCREW PULL BILATERALLY. REVISION PROCEDURE TO REPLACE L5 SCREWS AND FURTHER DECOMPRESS L5 NERVE ROOT FOR POST EVENT RADICULOPATHY. REPLACED L5 (6X40MM VERSE) SCREWS WITH 7X40MM VERSE SCREWS. TRIED TO RE-REDUCE THE SPONDYLOLITHESIS USING THE VERSE TABS USING CORRECTION KEYS. CORRECTION KEYS CROSS THREADED IN L5 SCREW TABS. THIS CONTINUED FOR 5 CORRECTION KEYS. USED THE QUICK STICK ALIGNMENT GUIDES TO TRY AND PREVENT CROSS THREADING. THE RIGHT 7X40MM SCREW THREAD STRIPPED. THE SURGEON REMOVED THE TABS AND USED THE VERSE THREADED REDUCTION TOOL FOR THE SPONDY REDUCTION. AT THIS POINT THE THREAD IN THE HEAD OF THE RIGHT 7X40MM SCREW IN L5 STRIPPED AWAY FROM THE TULIP AND HAD TO BE PICKED OUT OF THE OPERATIVE SIGHT WITH FORCEPS. THIS SCREW HAD PARTIALLY PULLED OUT OF THE PEDICLE AND WAS REMOVED AND REPLACED WITH AN 8X40MM SCREW. TABS WERE REMOVED, REDUCTION TOOL WAS USED BILATERALLY, SLIP REDUCED, UNITIZED SET SCREWS USED INSTEAD OF CORRECTION KEYS. NO CROSS THREADING THIS TIME. FINAL TORQUE

  Patient problems: Failure of Implant; Fall; Injury

  MAUDE report 6917456 ↗