EXPEDIUM VERSE 199723740SRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10705034444512), received between Aug 7, 2018 and Feb 19, 2024 — classified as 11 injuries, 1 malfunction.

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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 19, 2024Device Slipped; Device-Device Incompatibility; Device Slipped; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: THIS PC IS RELATED TO (B)(4) WHICH REPORTS A REMOVAL SURGERY PERFORMED ON (B)(6) 2024, DUE TO THE BEDSORE. THIS PC REPORTS LOOSENING OF A SCREW AND A SCREW REMOVAL DIFFICULTY OCCURRED IN THE REMOVAL SURGERY ON (B)(6) 2024. IT WAS REPORTED THAT THIS WAS THORACOLUMBAR POSTERIOR FUSION PERFORMED ON AN UNKNOWN DATE. IT IS UNKNOWN WHETHER JJ PRODUCTS WERE USED IN THE INITIAL SURGERY OR NOT. AFTER THE INITIAL SURGERY, A SECOND SURGERY WAS PERFORMED ON (B)(6) 2023, TO EXTEND THE FUSION FROM T9-L1 TO T9-L3. IN THE SURGERY, VERSE FENESTRATED SCREW IN QUESTION WAS USED AND 7.0-40 MM WERE INSERTED ON BOTH SIDES. THE AMOUNT OF THE CEMENT WAS 0.8 ON BOTH SIDES. AFTER THE EXTENSION SURGERY, THE REMOVAL SURGERY WAS PERFORMED ON (B)(6) 2024, FOR MULTIPLE OPERATED BACK DUE TO THE BEDSORE. BECAUSE OF NECROSIS OF THE MUSCLE, THE SCREW IN QUESTION ON LEFT L3 (LIV) WAS REMOVED. IN THE SURGERY, THE SKIN INCISIONS WERE DEPLOYED FROM L1 TO L3, AND THE SET SCREWS AT L3 AND L2 WERE REMOVED. RODS WERE CUT INSIDE THE BODY WITH A ROD-SIDE CUTTER, AND RODS L1-L2 WERE REMOVED. WHEN THE SURGEON ATTEMPTED TO MOVE THE HEAD ADJUSTER, IT WAS CONFIRMED T

  Patient problems: Insufficient Information; Necrosis

  MAUDE report 18730206 ↗
• InjuryFeb 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A THORACOLUMBAR POSTERIOR FUSION. AFTER THE INITIAL SURGERY, A SECOND SURGERY WAS PERFORMED ON (B)(6) 2023 TO EXTEND THE FUSION FROM T9-L1 TO T9-L3 WITH THE CEMENT IN QUESTION. THE AMOUNT OF THE CEMENT WAS .8CC ON BOTH SIDES, AND VERSE FENESTRATED SCREWS 7.0-40MM WERE INSERTED ON BOTH SIDES. AFTER THE EXTENSION SURGERY, THE REMOVAL SURGERY WAS PERFORMED ON (B)(6) 2024, FOR MULTIPLE OPERATED BACK DUE TO THE BEDSORE. BECAUSE OF NECROSIS OF THE MUSCLE, ONE OF THE SCREWS ON LEFT L3 (LIV) WAS PLANNED TO BE REMOVED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH OVER 30 MINUTES SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 7.0 X 40MM. THIS IS REPORT 1 OF 1 FOR (B)(4). (B)(4) ARE INVOLVED WITH THE SAME EVENT. (B)(4) REPORTS THE INVOLVED CEMENT, (B)(4) REPORTS THE SCREW. THIS PC IS RELATED TO (B)(4) WHICH REPORTS A LOOSENING OF A SCREW AND A SCREW REMOVAL DIFFICULTY OCCURRED IN THE REMOVAL SURGERY ON (B)(6) 2024.

  Patient problems: Necrosis; Pressure Sore/Ulcer

  MAUDE report 18701974 ↗
• InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A DATABASE RELATED RESEARCH ACTIVITY (DRRA): SPINE TANGO SOA REPORT - TLIF THE FOLLOWING COMPLICATIONS HAVE BEEN IDENTIFIED: INSTABILITY. COMPLICATION TIME/INTERVENTION. REPEAT SURGERY. THIS REPORT INVOLVES ONE EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 7.0 X 40MM THIS IS REPORT 4 OF 5 FOR (B)(4).

  Patient problems: Joint Laxity

  MAUDE report 18465919 ↗
• InjuryJan 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A DATABASE RELATED RESEARCH ACTIVITY (DRRA): SPINE TANGO SOA REPORT - TLIF. THE FOLLOWING COMPLICATIONS HAVE BEEN IDENTIFIED: HARDWARE REMOVAL, NON-UNION. COMPLICATION TIME/INTERVENTION. REPEAT SURGERY. THIS IS FOR DEPUY SYNTHES SPINE EXPEDIUM /OTHER AND EXPEDIUM VERSE FENESTRATED PRODUCTS. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information; Nonunion/Delayed-union Bone Fracture

  MAUDE report 18455313 ↗
• InjurySep 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A SPINAL FUSION (T10 TO L5) FOR THE SECONDARY POLYTRAUMA ON (B)(6) 2022. L1 AND L2 WERE THE VERTEBRAL TRAUMA, AND L4 WAS THE OBSOLETE COMPRESSION FRACTURE. L1 AND L2 BARELY HAD CENTRUMS, AND IT WAS A SURGERY TO GAIN POSTERIOR SUPPORT WITH THE VERSE FENESTRATED SCREWS IN QUESTION. SINCE THE PATIENT WAS ELDERLY, A VERTEBRAL BODY REPLACEMENT WAS NOT PERFORMED. THE EVENTS TOOK PLACE AS FOLLOWS: 1. THE SCREW IN QUESTION WAS INSERTED INTO T10 AS PER SURGICAL TECHNIQUE. 2. THE HA STICKS WERE INSERTED INTO T11 TO L2 AS PER SURGICAL TECHNIQUE. 3. THE SCREW IN QUESTION WAS INSERTED INTO L5, AND THE CEMENT WAS MIXED. 4. THE SCREW IN QUESTION WAS INSERTED INTO L4 WHILE MIXING THE CEMENT. 5. THE CEMENT WAS INSERTED INTO THE SCREW IN QUESTION BEFORE THE SCREW WAS INSERTED INTO L3. 6. THE CEMENT WAS INSERTED INTO L5 AND T10. THERE WAS NO CEMENT LEAKAGE. AFTER THE CEMENT WAS INSERTED INTO THE SCREWS IN QUESTION, THE BLOOD PRESSURE DROPPED RAPIDLY. THE HEART AND LUNGS WERE IN A STATE OF PAUSE. AFTER THE WOUND WAS CLOSED, THE CARDIOPULMONARY SYSTEM RETURNED. THE HYPOTENSION HAD NOT IMPROVED. THE SURGERY WA

  Patient problems: Embolism/Embolus; Low Blood Pressure/ Hypotension

  MAUDE report 15478280 ↗
• InjuryJul 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: ON (B)(6) 2022 THE PATIENT UNDERWENT A PRIMARY PLIF PROCEDURE. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY. THE FOLLOWING WERE POSTOPERATIVELY CONFIRMED: THE PATIENT HAD FEVER, AND THE TEMPERATURE DID NOT RETURN TO NORMAL. SOME PUS WAS DISCHARGED. AFTER THEY CONTINUED MEDICAL FOLLOW-UPS, THEY FINALLY CAME TO A CONCLUSION TO REMOVE THE IMPLANT IN QUESTION. THE REMOVAL PROCEDURE WAS COMPLETED ON (B)(6) 2022, AND THE PATIENT IS UNDER STABLE CONDITION. THEY DID NOT FIGURE OUT WHAT CAUSED THE EVENTS. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE FEN SCR 7.0X40. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 14958360 ↗
• MalfunctionDec 30, 2021Migration; Migration

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT A PPS (L2-SAI) FOR L5 FRACTURE DUE TO DISH ON (B)(6) 2021. THE SCREW WAS DEPLOYED IN L2 AND S1. NEXT, THE CEMENT WAS APPLIED STARTING AT L2 RIGHT. THE CEMENT WAS INJECTED FOURTEEN (14) MINUTES AFTER THE START OF CEMENT MIXING AS PER THE SURGICAL TECHNIQUE AT 24-DEGREES-CENTIGRADE ROOM TEMPERATURE; 0.8 ML OF CEMENT WAS APPLIED. THE SURGEON NOTED THAT THE CEMENT HAD LEAKED OUT OF THE CENTRUM. FURTHER CEMENT APPLICATION WAS STOPPED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE PATIENT STATUS WAS REPORTED AS STABLE. THIS REPORT IS FOR A EXPEDIUM VERSE SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4). THE CEMENT IS CAPTURED ON RELATED COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13118316 ↗
• InjuryJul 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE PATIENT WAS EXPECTED TO UNDERGO A REVISION SURGERY FOR REMOVING A SCREW AND EXTENDING THE FUSION UP TO THE ILIUM. THE PATIENT HAD POSTERIOR THORACOLUMBAR FUSION) AT TH9-L3 WAS PERFORMED ON (B)(6) 2021 FOR TREATING CENTRUM FRACTURE DUE TO OSTEOPOROSIS. THE CEMENT WAS APPLIED AT L3. THE PATIENT¿S L3 CENTRUM WAS FOUND FRACTURED WHERE THE CEMENT WAS APPLIED. THE PATIENT WAS IN PAIN. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) 5.5 EXP VERSE FEN SCR 7.0X40. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 12178014 ↗
• InjuryMar 26, 2020Migration; Migration

  IT WAS REPORTED THE PATIENT UNDER A L3-S1 POSTERIOR FUSION WITH PLIFS SPINAL FUSION PROCEDURE ON (B)(6) 2019. POST-OPERATIVELY, THE SET SCREW OF RIGHT S1 BECAME DISLODGED; ADDITIONALLY, THE ROD HAS PULLED OUT OF LEFT S1 SCREW. THE PATIENT EXPERIENCED PAIN AND ON (B)(6) 2020 UNDERWENT A REVISION PROCEDURE. THE PROCEDURE OUTCOME IS UNKNOWN. THIS REPORT IS FOR AN EXPEDIUM VERSE SCREW. THIS IS REPORT 1 OF 6 FOR (B)(4).

  Patient problems: Failure of Implant; Pain

  MAUDE report 9885383 ↗
• InjuryMar 25, 2020Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2020 THE BOTTOM LEVEL OF THE SET SCREW OF RIGHT S1 HAS BECOME DISLODGED. ADDITIONALLY THE ROD HAS PULLED OUT OF LEFT S1 SCREW. THERE WAS PAIN RESULTING IN REVISION SURGERY. THE PROCEDURE OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available; Pain

  MAUDE report 9881624 ↗
• InjuryAug 7, 2018Break; Break

  IT WAS REPORTED THAT SPINAL FIXATION OR SPONDY GRADE 2 S1-L5 WAS PERFORMED. SIX MONTHS AFTER SURGERY, THE TREATING PHYSICIAN NOTICED THAT ONE SCREW (RIGHT SIDE) WAS BROKEN, AND THE ROD HAD SLIPPED THROUGH THE SCREW HEAD IN S1 ON LEFT SIDE. RIGHT SIDE THE SCREW WAS BROKEN AND HAD ROTATED. ALSO THE ROD HAD SLIPPED THROUGH THE SCREW HEAD L5 ON THIS SIDE. ALL LOCKING CAPS WERE TIGHTENED ACCORDING TO THE SURGICAL TECHNIQUE AND DOUBLE CHECKED DURING SURGERY FOR CORRECT TORQUE LOCKING. THE ROD SLIPPAGE AND BREAKAGE HAS OCCURRED IN THE MONTHS AFTER THE SURGERY. THE SURGERY ITSELF WAS SUCCESSFUL AND NO POSTOPERATIVE EVENTS HAVE OCCURRED THAT MIGHT EXPLAIN THE SCREW BREAKAGE. THE PATIENT WAS TREATED FOR A SPONDY GRADE 2 AT LEVEL S1-L5. PRIMARY SURGERY DATE: (B)(6) 2017. PATIENT GENDER FEMALE. (B)(6). NO OTHER PATIENT DATA IS AVAILABLE

  Patient problems: Spinal Column Injury

  MAUDE report 7756710 ↗
• InjuryAug 7, 2018Break; Break

  IT WAS REPORTED THAT SPINAL FIXATION OR SPONDY GRADE 2 S1-L5 WAS PERFORMED. SIX MONTHS AFTER SURGERY THE TREATING PHYSICIAN NOTICED THAT ONE SCREW (RIGHT SIDE) WAS BROKEN, AND THE ROD HAD SLIPPED THROUGH THE SCREW HEAD IN S1 ON LEFT SIDE. RIGHT SIDE THE SCREW WAS BROKEN AND HAD ROTATED. ALSO THE ROD HAD SLIPPED THROUGH THE SCREW HEAD L5 ON THIS SIDE. ALL LOCKING CAPS WERE TIGHTENED ACCORDING TO THE SURGICAL TECHNIQUE AND DOUBLE CHECKED DURING SURGERY FOR CORRECT TORQUE LOCKING. THE ROD SLIPPAGE AND BREAKAGE HAS OCCURRED IN THE MONTHS AFTER THE SURGERY. THE SURGERY ITSELF WAS SUCCESSFUL AND NO POSTOPERATIVE EVENTS HAVE OCCURRED THAT MIGHT EXPLAIN THE SCREW BREAKAGE. THE PATIENT WAS TREATED FOR A SPONDY GRADE 2 AT LEVEL S1-L5. PRIMARY SURGERY DATE (B)(6) 2017. PATIENT GENDER FEMALE. DOB (B)(6). NO OTHER PATIENT DATA IS AVAILABLE.

  Patient problems: Spinal Column Injury

  MAUDE report 7756502 ↗