EXPEDIUM VERSE 199723540SRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705034443317), received between Nov 10, 2020 and Jul 1, 2022 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Migration” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2022Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED ON MAY 20, 2022, THAT THIS WAS A POSTERIOR FUSION FOR TREATING CENTRUM FRACTURE ON (B)(6) 2022. AFTER THE SCREW IN QUESTION WAS DEPLOYED, CEMENT WAS APPLIED IN THE LESION. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY. THE PATIENT WAS CT SCANNED NEXT DAY, AND THE SURGEON CONFIRMED CEMENT LEAKAGE. THIS WAS REPORTED AS FOLLOWS: 1. THE SCREW IN QUESTION SLIGHTLY CAME INTO CONTACT WITH THE CENTRUM¿S OUTER WALL. THE CEMENT LEAKED FROM THAT AREA. 2. THE PATIENT HAS BEEN UNDER STABLE CONDITION AND IS EXPECTED TO TAKE MEDICAL FOLLOW-UP. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE FEN SCR 5.0X40. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 14885522 ↗
• InjuryMar 21, 2022Break; Migration; Break; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2021 THE PATIENT UNDERWENT THE PRIMARY A SPINAL (THORACOLUMBAR) FUSION FOR TREATING ASD. THE SCREW IN QUESTION WAS DEPLOYED AT THE TOPMOST IN THE TREATED RANGE. ON AN UNKNOWN DATE THE CENTRUM (WHICH IS LOCATED OVER THE SCREW IN QUESTION) HAD FRACTURED. THE PATIENT IS SCHEDULED TO UNDERGO A REVISION PROCEDURE ON (B)(6) 2022. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE 5.5 EXP VERSE FEN SCR 5.0X40. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13841529 ↗
• InjuryFeb 1, 2021Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, A WEEK AFTER THE POSTERIOR SPINAL FUSION TREATING OSTEOPOROTIC VERTEBRAL BODY FRACTURE PROCEDURE, THE PATIENTS CT SCAN SHOWED THAT THE CEMENT HAD LEAKED OUT AND THE SCREW HAD BACK OUT. THE PATIENT HAD THE INITIAL PROCEDURE ON (B)(6) 2021. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. THIS REPORT INVOLVES ONE (1) EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.0 X 40MM. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS (B)(4) IS RELATED TO (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11258483 ↗
• InjuryNov 24, 2020Device Slipped; Device Slipped

  IT WAS REPORTED THAT ON (B)(6) 2020 THE PATIENT HAD LOOSENING OF SCREWS AND REQUIRED A RE-ARTHRODESIS. ALL SCREWS WERE SUCCESSFULLY REMOVED FROM LEFT/RIGHT - L3, L4, L5, S1, IL. THERE WAS A FIVE (5) MINUTE SURGICAL DELAY AND PROCEDURE OUTCOME WAS UNKNOWN. THERE WAS NO PATIENT HARM/CONSEQUENCE. CONCOMITANT DEVICES: EXPEDIUM 5.5MM TITANIUM RODS(PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 2); 5.5 EXP VERSE UNITIZED SET SCR (PART # 199721001, LOT # UNKNOWN, QUANTITY # 8); SINGLE-INNER SETSCREW (PART # 179702000, LOT # UNKNOWN, QUANTITY # 2). THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE FEN SCR 5.0X40. THIS IS REPORT 6 OF 8 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 10890927 ↗
• InjuryNov 24, 2020Device Slipped; Device Slipped

  IT WAS REPORTED THAT ON (B)(6) 2020 THE PATIENT HAD LOOSENING OF SCREWS AND REQUIRED A RE-ARTHRODESIS. ALL SCREWS WERE SUCCESSFULLY REMOVED FROM LEFT/RIGHT - L3, L4, L5, S1, IL. THERE WAS A FIVE (5) MINUTE SURGICAL DELAY AND PROCEDURE OUTCOME WAS UNKNOWN. THERE WAS NO PATIENT HARM/CONSEQUENCE. CONCOMITANT DEVICES: EXPEDIUM 5.5MM TITANIUM RODS(PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 2). 5.5 EXP VERSE UNITIZED SET SCR (PART # 199721001, LOT # UNKNOWN, QUANTITY # 8). SINGLE-INNER SETSCREW (PART # 179702000, LOT # UNKNOWN, QUANTITY # 2). THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE FEN SCR 5.0X40. THIS IS REPORT 2 OF 8 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 10890130 ↗
• MalfunctionNov 10, 2020Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 WHILE INSERTING THE NUT, JUST PAST THE WING OF THE VERSE SCREW, THE NUT BEGAN TO FILLET. ANOTHER NUT WAS TRIED WITHOUT SUCCESS. THIS HAPPENED ON THREE (3) SCREWS WHICH HAD TO BE REPLACED. ONE OF THE SCREWS WAS INSERTED WITH A LARGER DIAMETER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 120 MINUTE DELAY. THIS REPORT IS FOR ONE (1) EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.0 X 40MM. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10817570 ↗