EXPEDIUM VERSE 199723635Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705034403106), received between Aug 28, 2017 and Jul 23, 2021 — classified as 4 injuries, 1 malfunction.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 23, 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. CONCOMITANT DEVICES: UNKNOWN TORQUE HANDLE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 2) UNKNOWN RODS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN)) THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE FEN SCR 6.0X35. THIS IS REPORT 2 OF 14 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12218288 ↗
• InjuryJun 5, 2020Break; Break

  UPDATED: CONCOMITANT DEVICE REPORTED: EXPEDIUM VERSE SPINE SYSTEM UNITIZED SET SCREW 5.5 (PART #: 199721001, LOT #: WC1321, QUANTITY 3); EXPEDIUM VERSE SPINE SYSTEM UNITIZED SET SCREW 5.5 (PART #: 199721001, LOT #: VJ1231, QUANTITY 2); EXPEDIUM SPINE SYSTEM PRE-BENT SPINAL ROD 5.5 X 65MM (PART #: 179772065, SERIAL OR LOT #: (B)(6)QUANTITY 2); 5.5 EXP VERSE FEN SCW 6.0 (199723645, LOT UNKNOWN, QUANTITY 4); 5.5 EXP VERSE UNITIZED SET (199721001,LOT UNKNOWN, QUANTITY 1).

  Patient problems: No Code Available

  MAUDE report 10122993 ↗
• InjuryMay 21, 2020Break; Break

  UPDATED ED: THE BROKEN SCREW WAS NOTICED WHEN AFTER REMOVING THE ROD AND SET SCREW, NO DRIVER WAS ON THE BROKEN SCREW AT THE TIME IT WAS DISCOVERED, WE THEN CONFIRMED ON PREOPERATIVELY IMAGING THAT THE SCREW WAS ALREADY BROKEN.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10079147 ↗
• InjuryJan 8, 2020Crack; Crack

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE STABILIZATION SYSTEM IMPLANTED ON THE PATIENT WAS DISMANTLED DUE TO THE BREAKING OF TWO TIGHTENING NUTS AND IT WAS NECESSARY TO RE-OPERATE THE PATIENT TO REMOVE AND REPLACE THE FAULTY SYSTEM. THE DEVICES WERE REMOVED. NO FURTHER INFORMATION PROVIDED. UPON RECEIPT OF THE DEVICES AT MANUFACTURING SITE IT WAS IDENTIFIED THAT 5.5 EXP VERSE FEN SCREW 6.0 X 35 HAS TORN THREADS. CONCOMITANT DEVICES: UNKNOWN SET SCREW (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY: UNKNOWN) AND UNKNOWN ROD (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE FEN SCR 6.0 X 35. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available

  MAUDE report 9565222 ↗
• InjuryAug 28, 2017Loose or Intermittent Connection; Loose or Intermittent Connection

  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 6X40MM FRACTURE THROUGH THE VERTEBRAL BODY OF S1 ON THE LEFT SIDE. THE RIGHT SIDE L5 SCREW HAD ALSO DISCONNECTED WITH THE 35MM 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 (6X40MM AT S1 AND 6X35MM L5) AND MEDTRONIC R90 IMPLANTS (PLIF CAGE).THEN REPLACED THE SCREWS AT L5 WITH X2 7X35MM SCREWS AND X1 7X40MM AT S1 LEFT SIDE AND X1 7X35 AT S1 RIGHT SIDE. HE ALSO PLACE SAI (SACRAL ALAR ILIAC SCREWS) 8X80MM 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 6824892 ↗