EXPEDIUM VERSE 199723640SRecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10705034443492), received between Nov 24, 2020 and Dec 30, 2025 — classified as 17 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 18, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryDec 30, 2025Migration; Migration

  IT WAS REPORTED THAT THE PRIMARY SURGERY WAS ON (B)(6) 2024, WHEN THE FOUR SCREWS WERE INSERTED, WITH CEMENT USED FOR ALL SCREWS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. HOWEVER, AFTER THE SURGERY, THE IMPLANTS HAD COME OUT TO THE EXTENT THAT THEY WERE VISIBLE FROM THE PATIENT'S BACK, CAUSING A BEDSORE. THE PATIENT HAD A MENTAL ILLNESS AND HAD BEEN MOVING VIOLENTLY SINCE IMMEDIATELY AFTER SURGERY. WHEN THE IMPLANTS WERE ACTUALLY REMOVED ON (B)(6) 2025, TWO SCREWS ON THE RIGHT WERE FOUND TO HAVE BROKEN. THEY WERE LIKELY BROKEN AT THE INTERFACE WITH THE CEMENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 23924771 ↗
• InjuryDec 30, 2025Break; Migration; Break; Migration

  IT WAS REPORTED THAT THE PRIMARY SURGERY WAS ON (B)(6) 2024, WHEN THE FOUR SCREWS WERE INSERTED, WITH CEMENT USED FOR ALL SCREWS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. HOWEVER, AFTER THE SURGERY, THE IMPLANTS HAD COME OUT TO THE EXTENT THAT THEY WERE VISIBLE FROM THE PATIENT'S BACK, CAUSING A BEDSORE. THE PATIENT HAD A MENTAL ILLNESS AND HAD BEEN MOVING VIOLENTLY SINCE IMMEDIATELY AFTER SURGERY. WHEN THE IMPLANTS WERE ACTUALLY REMOVED ON (B)(6) 2025, TWO SCREWS ON THE RIGHT WERE FOUND TO HAVE BROKEN. THEY WERE LIKELY BROKEN AT THE INTERFACE WITH THE CEMENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 23924756 ↗
• InjuryDec 30, 2025Migration; Migration

  IT WAS REPORTED THAT THE PRIMARY SURGERY WAS ON (B)(6) 2024, WHEN THE FOUR SCREWS WERE INSERTED, WITH CEMENT USED FOR ALL SCREWS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. HOWEVER, AFTER THE SURGERY, THE IMPLANTS HAD COME OUT TO THE EXTENT THAT THEY WERE VISIBLE FROM THE PATIENT'S BACK, CAUSING A BEDSORE. THE PATIENT HAD A MENTAL ILLNESS AND HAD BEEN MOVING VIOLENTLY SINCE IMMEDIATELY AFTER SURGERY. WHEN THE IMPLANTS WERE ACTUALLY REMOVED ON (B)(6) 2025, TWO SCREWS ON THE RIGHT WERE FOUND TO HAVE BROKEN. THEY WERE LIKELY BROKEN AT THE INTERFACE WITH THE CEMENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 23924755 ↗
• InjuryDec 30, 2025Break; Migration; Break; Migration

  IT WAS REPORTED THAT THE PRIMARY SURGERY WAS ON (B)(6) 2024, WHEN THE FOUR SCREWS WERE INSERTED, WITH CEMENT USED FOR ALL SCREWS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. HOWEVER, AFTER THE SURGERY, THE IMPLANTS HAD COME OUT TO THE EXTENT THAT THEY WERE VISIBLE FROM THE PATIENT'S BACK, CAUSING A BEDSORE. THE PATIENT HAD A MENTAL ILLNESS AND HAD BEEN MOVING VIOLENTLY SINCE IMMEDIATELY AFTER SURGERY. WHEN THE IMPLANTS WERE ACTUALLY REMOVED ON (B)(6) 2025, TWO SCREWS ON THE RIGHT WERE FOUND TO HAVE BROKEN. THEY WERE LIKELY BROKEN AT THE INTERFACE WITH THE CEMENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 23924754 ↗
• InjuryFeb 6, 2025Break; Break

  IT WAS REPORTED THAT THIS WAS A PLF (L2-5) FOR SPINAL STENOSIS ON (B)(6) 2023. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER THE SURGERY, THE VERSE FENESTRATED SCREW WAS FOUND TO BE BROKEN OFF DURING THE FIXATION EXTENSION SURGERY PERFORMED ON (B)(6) 2025. THE BROKEN VERSE FENESTRATED SCREW WAS REMOVED IN THE FIXATION EXTENSION SURGERY. IT HAS BEEN MORE THAN 1 YEAR SINCE THE VERSE FENESTRATED SCREW WAS IMPLANTED IN THE BODY, AND IT IS LIKELY THAT THE VERSE FENESTRATED SCREW WAS BROKEN OFF DUE TO SOME KIND OF LOAD CAUSED BY A FALL OR OTHER ACCIDENT. PATIENT OUTCOME IS REPORTED TO BE STABLE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Fall

  MAUDE report 21323199 ↗
• InjuryOct 30, 2024Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE IMPLANT HAS BEEN WITHIN THE PATIENT FOR 4 MONTHS. REVISION SURGERY WAS PERFORMED WHERE THE IMPLANT WAS REMOVED DUE TO THE BROKEN SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20569176 ↗
• InjuryOct 30, 2024Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE IMPLANT HAS BEEN WITHIN THE PATIENT FOR 4 MONTHS. REVISION SURGERY WAS PERFORMED WHERE THE IMPLANT WAS REMOVED DUE TO THE BROKEN SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20569168 ↗
• MalfunctionSep 27, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT PATIENT UNDERWENT A THORACIC SPINAL FUSION ON (B)(6) 2024. THE SURGEON USED A UNITIZED SETSCREW FOR A SCREW AND TIGHTENED IT FIRMLY TO FASTEN THE ROD. THE SURGEON THEN WANTED TO REDO THE ROD BENDING, SO HE TRIED TO MOVE THE HEAD OF THE SCREW ONCE THE UNITIZED SETSCREW WAS REMOVED. HOWEVER, THE ROD COULD NOT BE RETIGHTENED BECAUSE THE HEAD WAS LOCKED, ALTHOUGH THE FINAL FASTENING HAD NOT BEEN MADE AT THAT POINT. HENCE, THE SCREW WAS REPLACED WITH A NEW ONE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN THIRTY MINUTES SURGICAL DELAY. THIS REPORT IS FOR A 5.5 EXP VERSE FEN SCR 6.0X40.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20321392 ↗
• MalfunctionNov 28, 2023Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2023, AFTER INSERTION OF THE SCREW IN QUESTION INTO THE VERTEBRAL BODY, THE SCREWDRIVER WAS ROTATED TO THE LEFT FOR REMOVAL, BUT THE SCREW COULD NOT BE REMOVED, AND IT SLIPPED OUT OF THE VERTEBRAL BODY. THE SURGEON INSERTED A LARGER SCREW. THE REASON FOR THE EVENT IS UNKNOWN. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. THE PATIENT STATUS WAS REPORTED TO BE STABLE. THIS REPORT INVOLVES ONE EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 6.0 X 40MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18219902 ↗
• MalfunctionAug 30, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SPAIN AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, THAT THE VERSE ADVANCED SCREW LOCKING ONCE THEY HAVE BEEN CLOSED DYNAMOMETRICALLY WITH DOUBLE CLOSURE AND CONVERTED TO MONOAXIAL. IT WAS NECESSARY TO REMOVE THE WORKING BAR TO BE ABLE TO CONTINUE WITH THE SURGERY AND THE HEADS REMAINED BLOCKED WITH RESPECT TO THE STEM TOWARDS THE SIDE OF THE FAVORED ANGLE. SURGERY WAS DELAYED FOR 30 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. THERE WAS NO PATIENT OUTCOME/CONSEQUENCES. THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE FEN SCR 6.0X40. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15321955 ↗
• MalfunctionAug 30, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SPAIN AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, THAT THE VERSE ADVANCED SCREW LOCKING ONCE THEY HAVE BEEN CLOSED DYNAMOMETRICALLY WITH DOUBLE CLOSURE AND CONVERTED TO MONOAXIAL. IT WAS NECESSARY TO REMOVE THE WORKING BAR TO BE ABLE TO CONTINUE WITH THE SURGERY AND THE HEADS REMAINED BLOCKED WITH RESPECT TO THE STEM TOWARDS THE SIDE OF THE FAVORED ANGLE. SURGERY WAS DELAYED FOR 30 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. THERE WAS NO PATIENT OUTCOME/CONSEQUENCES. THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE FEN SCR 6.0X40. THIS IS REPORT 1 OF 3 FOR COMPLAINT: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15321930 ↗
• MalfunctionAug 30, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SPAIN AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, THAT THE VERSE ADVANCED SCREW LOCKING ONCE THEY HAVE BEEN CLOSED DYNAMOMETRICALLY WITH DOUBLE CLOSURE AND CONVERTED TO MONOAXIAL. IT WAS NECESSARY TO REMOVE THE WORKING BAR TO BE ABLE TO CONTINUE WITH THE SURGERY AND THE HEADS REMAINED BLOCKED WITH RESPECT TO THE STEM TOWARDS THE SIDE OF THE FAVORED ANGLE. SURGERY WAS DELAYED FOR 30 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. THERE WAS NO PATIENT OUTCOME/CONSEQUENCES. THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE FEN SCR 6.0X40 THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15321918 ↗
• InjuryJun 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT A PATIENT WHO HAD UNDERGONE A PRIMARY SPINAL FUSION ON (B)(6) 2022 EXPERIENCED PAIN TWO WEEKS LATER. AFTER INVESTIGATION, IT WAS CONFIRMED THAT A FRACTURE WAS PRESENT IN THE CENTRUM WHERE THE CEMENT WAS INJECTED. THE PATIENT IS CURRENTLY UNDER CONSERVATIVE TREATMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 14688226 ↗
• InjuryJul 21, 2021Break; Break

  IT WAS REPORTED THAT IN (B)(6) 2021, THE PATIENT HAD A POST-OPERATIVE L2 FRACTURE EIGHT (8) MONTHS POST OP. THE ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2020. THE SURGEON DECIDED TO MONITOR THE PATIENT AND ULTIMATELY DECIDED TO REVISE THE PATIENT ON (B)(6) 2021. THE L2 SCREWS WERE REMOVED AND THE PATIENT WAS REVISED WITH T11-L1 POSTERIOR LATERAL FIXATION WITH CONNECTION TO PREVIOUS ROD CONSTRUCT. THE PATIENT AND SURGICAL OUTCOME ARE UNKNOWN. THERE IS NO FURTHER INFORMATION AVAILABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN ROD CONSTRUCT (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE FEN SCR 6.0X40. THIS IS REPORT 2 OF 2 FOR (B)(4).

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

  MAUDE report 12205255 ↗
• InjuryJul 21, 2021Break; Break

  IT WAS REPORTED THAT IN (B)(6) OF 2021, THE PATIENT HAD A POST-OPERATIVE L2 FRACTURE EIGHT (8) MONTHS POST OP. THE ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2020. THE SURGEON DECIDED TO MONITOR THE PATIENT AND ULTIMATELY DECIDED TO REVISE THE PATIENT ON (B)(6) 2021. THE L2 SCREWS WERE REMOVED AND THE PATIENT WAS REVISED WITH T11-L1 POSTERIOR LATERAL FIXATION WITH CONNECTION TO PREVIOUS ROD CONSTRUCT. THE PATIENT AND SURGICAL OUTCOME ARE UNKNOWN. THERE IS NO FURTHER INFORMATION AVAILABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN ROD CONSTRUCT (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE FEN SCR 6.0X40. THIS IS REPORT 1 OF 2 FOR (B)(4).

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

  MAUDE report 12205105 ↗
• InjuryJun 17, 2021Break; Break

  ON (B)(6) 2021, REVISION SPINAL HARDWARE LUMBAR SPINE WITH REFUSION FROM T12-L3 DUE TO BROKEN SCREWS L3 WITH LOOSE SCREW LEFT L3. THE SCREWS AT L3 WERE REMOVED NOTED TO BE LOOSE THEY CAME OUT WITH THE TIPS OF THE SCREW IN THE DEEPEST OF THE PEDICLE.

  Patient problems: Insufficient Information

  MAUDE report 12021611 ↗
• InjuryJun 17, 2021Break; Break

  ON (B)(6) 2021, REVISION SPINAL HARDWARE LUMBAR SPINE WITH REFUSION FROM T12-L3 DUE TO BROKEN SCREWS L3 WITH LOOSE SCREW LEFT L3. THE SCREWS AT L3 WERE REMOVED NOTED TO BE LOOSE THEY CAME OUT WITH THE TIPS OF THE SCREW IN THE DEEPEST OF THE PEDICLE.

  Patient problems: Insufficient Information

  MAUDE report 12020609 ↗
• InjuryNov 24, 2020Device Slipped; Device Slipped

  UPDATED CONCOMITANT DEVICE REPORTED: EXPEDIUM 5.5MM TITANIUM RODS (PART UNKNOWN, LOT UNKNOWN, QUANTITY 2); 5.5 EXP VERSE UNITIZED SET SCREW (PART 199721001, LOT UNKNOWN, QUANTITY 8); SINGLE-INNER SETSCREW (PART 179702000, LOT UNKNOWN, QUANTITY 2); 5.5 EXP VERSE FEN SCREW 7.0X40 (PART 199723740S, LOT UNKNOWN, QUANTITY 2).

  Patient problems: Failure of Implant

  MAUDE report 10898497 ↗
• 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 6.0X40. THIS IS REPORT 7 OF 8 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 10891668 ↗
• 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 6.0X40. THIS IS REPORT 5 OF 8 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 10890959 ↗
• 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 6.0X40. THIS IS REPORT 1 OF 8 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 10890033 ↗
• 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 SET SCREW (PART # 179702000, LOT # UNKNOWN, QUANTITY # 2). THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE FEN SCR 6.0X40. THIS IS REPORT 3 OF 8 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 10889976 ↗