EXPEDIUM VERSE 299704272Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034477206), received between Oct 22, 2017 and Dec 13, 2022 — classified as 1 injury, 3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 13, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT DURING A SPINAL FUSION PROCEDURE ON (B)(6) 2022, THE SURGEON WAS ATTEMPTING TO ATTACH THE FLEX CLIP REDUCER HANDLE TO THE FLEX CLIP REDUCER THREADED INSERT. THEY WERE NOT ABLE TO ATTACH IT AS THE FLEX CLIP REDUCER THREADED INSERT WAS TOO THICK. THE FLEX CLIP REDUCER INSERT WAS EXCHANGED FOR ONE IN THE VERSE STD SET AND IT WORKED. THE PATIENT APPEARED TO BE UNAFFECTED. AN EXTRA 10 MINUTES OF SURGERY TIME WAS ADDED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE EXPEDIUM VERSE SPINE SYSTEM FLEX CLIP REDUCER, THREADED INSERT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15969839 ↗
• MalfunctionNov 18, 2022Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PLASTIC RING OF THE EV CLIP ON THE REDUCER REDUCT TIP WAS BROKEN AND RELEASED THE PIECE INSIDE THE CLIP ON. IT THEN DIDN¿T ALLOW THE REMOVAL OF THE CLIP ON FROM THE TOP NOTCH OF THE SCREW HEAD. SURGERY WAS DELAYED BY 15 MINUTES AS A RESULT OF THIS EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE EXPEDIUM VERSE SPINE SYSTEM FLEX CLIP REDUCER, THREADED INSERT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15822393 ↗
• MalfunctionJun 22, 2022Break; Break

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2022, THE INSTRUMENTS BROKE. THIS REPORT IS FOR AN EXPEDIUM VERSE SPINE SYSTEM FLEX CLIP REDUCER, THREADED INSERT. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14773990 ↗
• InjuryOct 22, 2017Difficult to Remove; Difficult to Remove

  L5-S1 POSTERIOR LATERAL INTERBODY FUSION. DEVICE IS USED AS A TWO PART DEVICE. THREADED INSERTER 2997 04 272 JAMMED IN 2997 04 270 WHILE SURGEON WAS USING. TABS ON PEDICLE SCREW WERE BROKEN, AND REDUCTION INSTRUMENTS WERE NEEDED TO PERFORM REDUCTION TECHNIQUE. FLEX CLIP WAS ATTACHED ONTO TOP NOTCH OF PEDICLE SCREW . THREADER INSERTER THEN INSERTED INTO FLEX CLIP TO PERFORM REDUCTION, WHILE WINDING DOWN ON BLACK REDUCER HANDLE, A CRACK WAS HEARD. NO MORE INSERTION WAS POSSIBLE. REDUCTION WAS NOT PERFORMED, SURGEON WOUND OUT 2997 04 272. FLEX CLIP 2997 04 270 WAS UNCLIPPED FROM PEDICLE SCREW USING A BONE RONGEUER. PIECE OF 2997 04 272 STILL STUCK IN 2997 04 270. THIRTY MINUTE DELAY TO PROCEDURE. NO AE TO PATIENT. 'PRODUCT DISCARDED' HAS BEEN SELECTED FOR PRODUCT STATUS IN THIS INSTANCE AS THERE IS NO APPROPRIATE STATUS AVAILABLE TO REPRESENT THE FOLLOWING LOCAL PROCESS: INSTRUMENT WILL BE SENT TO LOCAL ENGINEERING FOR ASSESSMENT OF WEAR AND TEAR. IF 'WEAR AND TEAR' IS ASSIGNED, A COPY OF THE LOCAL ASSESSMENT WILL BE PROVIDED TO THE MANUFACTURER FOR THEIR RECORD AND CASE CLOSURE. IN THE CASE WEAR AND TEAR CANNOT BE ASSIGNED BY THE ENGINEER, THE PRODUCT WILL BE RETURNED TO THE MANUFACT

  Patient problems: Injury

  MAUDE report 6967840 ↗