EXPEDIUM VERSE 199721001SRecalls & reported problems

Summary

The FDA's MAUDE database contains 124 adverse event reports that list this exact device (DI 10705034466149), received between Nov 8, 2017 and Aug 6, 2026 — classified as 88 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Break” (18 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 25 most recent of 124 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2026Break; Device Slipped

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50161236 ↗
• MalfunctionAug 5, 2026Break; Device Slipped

  It was reported that during the OR, when fixing the rod, the Expedium Verse correction keys were placed by a facilitator tube, as prescribed by the STG.While tightening these correction keys, metal came off the screw head and the correction key no longer had a grip. Subsequently, a unitized set screw was placed. It also had no grip and kept turning. also two other screws in the construction of a total of 6 screws, gave the same problem: overturning the Expedium Verse correction keys and the subsequent unitized set screw; as a rescue option.All three screws were then explanted and replaced by new ones.Because of this incident, the operating area had to be checked extra for metal residues. No other metal remains were found. All metal residues found have been removed.by changing the broken screws, there has been a considerable delay in the total OR time.Also, 3 extra implants had to be used to bring the OR to a successful conclusion.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50147986 ↗
• InjuryJan 8, 2026Device Slipped

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PLF (L1/2, L5/S) SURGERY ON (B)(6) 2025. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THE SURGEON USED THE VERSE SCREWS AND UNIOS(POLO) FOR THE SURGERY. THE RODS WERE NOT CONNECTED ABOVE AND BELOW BUT WERE FIXED AT L1/2 AND L5/S1 RESPECTIVELY. ON (B)(6) 2025, THE POSTOPERATIVE X-RAY REVEALED THAT BOTH SIDE OF THE SET SCREWS IN L1 HAD COME LOOSE. A REVISION SURGERY WAS SCHEDULED FOR (B)(6) 2026. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 24007247 ↗
• InjuryJan 8, 2026Device Slipped

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PLF (L1/2, L5/S) SURGERY ON (B)(6) 2025. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THE SURGEON USED THE VERSE SCREWS AND UNIOS(POLO) FOR THE SURGERY. THE RODS WERE NOT CONNECTED ABOVE AND BELOW BUT WERE FIXED AT L1/2 AND L5/S1 RESPECTIVELY. ON (B)(6) 2025, THE POSTOPERATIVE X-RAY REVEALED THAT BOTH SIDE OF THE SET SCREWS IN L1 HAD COME LOOSE. A REVISION SURGERY WAS SCHEDULED FOR (B)(6) 2026. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 24007241 ↗
• MalfunctionDec 29, 2025Migration; Migration

  IT WAS REPORTED THAT THIS WAS AN UNKNOWN SURGERY(L4-SAI) PERFORMED ON (B)(6) 2023. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. AFTER THE SURGERY, AN X-RAY TAKEN ON (B)(6) 2025 REVEALED THAT THE SET SCREW IN THE PATIENT'S LEFT L4 BONE HAD BECOME DISLODGED INTERNALLY. SIMILAR INCIDENTS HAVE OCCURRED AT THIS HOSPITAL IN THE PAST, AND THE SALES REP HAVE BEEN ASKED FOR OUR COMPANY'S OPINION. THE PATIENT IN THIS CASE HAS COMPLETED BONE HEALING AT THE OPERATED SITE, SO THE SALES REP IS UNABLE TO CONFIRM ANY PLANS FOR FURTHER SURGERY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23914686 ↗
• MalfunctionDec 23, 2025Break; Device Slipped; Break; Device Slipped

  IT WAS REPORTED DURING TH3-L1/2 PROCEDURE WHILE TIGHTENING THE SET SCREWS, METAL FRAGMENTS ARE COMING LOOSE. SURGERY WAS DELAYED 30 MINUTES. FRAGMENTS WERE REMOVED FROM PATIENT. PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23876187 ↗
• MalfunctionDec 23, 2025Break; Device Slipped; Break; Device Slipped

  IT WAS REPORTED DURING TH3-L1/2 PROCEDURE WHILE TIGHTENING THE SET SCREWS, METAL FRAGMENTS ARE COMING LOOSE. SURGERY WAS DELAYED 30 MINUTES. FRAGMENTS WERE REMOVED FROM PATIENT. PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23876120 ↗
• InjurySep 4, 2025Break; Break

  IT WAS REPORTED THAT THIS WAS AN UNKNOWN SURGERY PERFORMED FOR LUMBAR SPINE ON AN UNKNOWN DATE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. AFTER THE SURGERY, IT WAS CONFIRMED THAT THE SCREW PREVIOUSLY USED IN THE LUMBAR SPINE BROKE AT THE BOTTOM OF THE SCREW. WE ARE CONFIRMING ABOUT DETAILS. THE REOPERATION WILL BE PERFORMED ON (B)(6) 2025 AT DIFFERENT HOSPITAL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 22964803 ↗
• MalfunctionApr 23, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THE EXPEDIUM VERSE SYSTEM WAS USED DURING A PROCEDURE AND DURING INSERTION, A SCREW 7MM L50 COULD NOT BE INSERTED. THE SCREW LOOSENED WHEN THE SET SCREW WAS SCREWED IN. IN ADDITION, A TOTAL OF FIVE SET SCREWS COULD NOT BE SCREWED IN, AS THEY WERE PARTIALLY BROKEN DURING THE SCREW-IN TEST. NO BROKEN FRAGMENTS WERE RETAINED IN THE PATIENT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 15 MINUTE SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 21890658 ↗
• InjuryApr 8, 2025Device Slipped; Device Slipped

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE PATIENT WAS STABLE.

  Patient problems: Loss of Range of Motion

  MAUDE report 21800474 ↗
• MalfunctionApr 8, 2025Break; Break

  IT WAS REPORTED THAT A TLIF (L4) FOR SPINAL CANAL STENOSIS WAS PERFORMED. THE SET SCREW BROKE DURING FINAL TIGHTENING, SO FINAL TIGHTENING WAS NOT POSSIBLE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES OF SURGICAL DELAY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21795860 ↗
• MalfunctionMar 26, 2025Device Slipped; Device Slipped

  IT WAS REPORTED THAT A POSTERIOR SPINAL FUSION (LUMBER 2-5) FOR ADULT SPINAL DEFORMITY ON M(B)(6) 2025 WAS PERFORMED. L2-SAI WAS FIXED FOR ASD. LLIF HAD BEEN PERFORMED ON L2/3/4/5 A WEEK AGO. FROM THE POSTERIOR SIDE, PLIF OF L5/S AND POSTERIOR FUSION OF L2-SAI WERE PERFORMED. IN THE SURGERY, AFTER INSERTING THE SAI AND VERSE SCREW, THE ROD AND SET SCREWS WERE PLACED, AND APPLIED FINAL OF THE SET SCREW WAS PERFORMED FROM THE SAI. FROM S1, AFTER FINALIZING THE LOWER PART, THE SURGEON FINALIZED WHILE APPLYING COMPRESSION TO THE UPPER PART. FINALS WERE PERFORMED ON ALL SET SCREWS. LATER, WHILE USING A SPECIAL INSTRUMENT TO BREAK OFF THE SCREW'S REDUCTION TAB, THE SURGEON AND HIS ASSISTANT NOTICED THAT THE SCREW HEAD WAS LOOSE. THEREFORE, THE SURGEON AGAIN APPLIED COMPRESSION AND FINALIZED THE SET SCREWS. THE SURGEON CONFIRMED THAT THE SET SCREWS WERE NOT FLOATING AWAY FROM THE SCREW HEAD AND COMPLETED THE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21696498 ↗
• MalfunctionMar 26, 2025Device Slipped; Device Slipped

  IT WAS REPORTED THAT A POSTERIOR SPINAL FUSION (LUMBER 2-5) FOR ADULT SPINAL DEFORMITY ON (B)(6) 2025 WAS PERFORMED. L2-SAI WAS FIXED FOR ASD. LLIF HAD BEEN PERFORMED ON L2/3/4/5 A WEEK AGO. FROM THE POSTERIOR SIDE, PLIF OF L5/S AND POSTERIOR FUSION OF L2-SAI WERE PERFORMED. IN THE SURGERY, AFTER INSERTING THE SAI AND VERSE SCREW, THE ROD AND SET SCREWS WERE PLACED, AND APPLIED FINAL OF THE SET SCREW WAS PERFORMED FROM THE SAI. FROM S1, AFTER FINALIZING THE LOWER PART, THE SURGEON FINALIZED WHILE APPLYING COMPRESSION TO THE UPPER PART. FINALS WERE PERFORMED ON ALL SET SCREWS. LATER, WHILE USING A SPECIAL INSTRUMENT TO BREAK OFF THE SCREW'S REDUCTION TAB, THE SURGEON AND HIS ASSISTANT NOTICED THAT THE SCREW HEAD WAS LOOSE. THEREFORE, THE SURGEON AGAIN APPLIED COMPRESSION AND FINALIZED THE SET SCREWS. THE SURGEON CONFIRMED THAT THE SET SCREWS WERE NOT FLOATING AWAY FROM THE SCREW HEAD AND COMPLETED THE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21696481 ↗
• MalfunctionMar 26, 2025Device Slipped; Device Slipped

  IT WAS REPORTED THAT A POSTERIOR SPINAL FUSION (LUMBER 2-5) FOR ADULT SPINAL DEFORMITY ON (B)(6) 2025 WAS PERFORMED. L2-SAI WAS FIXED FOR ASD. LLIF HAD BEEN PERFORMED ON L2/3/4/5 A WEEK AGO. FROM THE POSTERIOR SIDE, PLIF OF L5/S AND POSTERIOR FUSION OF L2-SAI WERE PERFORMED. IN THE SURGERY, AFTER INSERTING THE SAI AND VERSE SCREW, THE ROD AND SET SCREWS WERE PLACED, AND APPLIED FINAL OF THE SET SCREW WAS PERFORMED FROM THE SAI. FROM S1, AFTER FINALIZING THE LOWER PART, THE SURGEON FINALIZED WHILE APPLYING COMPRESSION TO THE UPPER PART. FINALS WERE PERFORMED ON ALL SET SCREWS. LATER, WHILE USING A SPECIAL INSTRUMENT TO BREAK OFF THE SCREW'S REDUCTION TAB, THE SURGEON AND HIS ASSISTANT NOTICED THAT THE SCREW HEAD WAS LOOSE. THEREFORE, THE SURGEON AGAIN APPLIED COMPRESSION AND FINALIZED THE SET SCREWS. THE SURGEON CONFIRMED THAT THE SET SCREWS WERE NOT FLOATING AWAY FROM THE SCREW HEAD AND COMPLETED THE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21696464 ↗
• MalfunctionDec 11, 2024Inaccurate Information; Inaccurate Information

  IT WAS REPORTED THAT THE UNITIZED SET SCREW BOX REF 199721001S WAS OPENED, AND THERE WAS A DIFFERENT PRODUCT REF 179702000S INSIDE. THERE WAS NO SURGICAL DELAY AND NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20906311 ↗
• MalfunctionAug 20, 2024Migration; Migration

  IT WAS REPORTED THAT THIS WAS AN UNKNOWN SURGERY PERFORMED ON (B)(6) 2023. ON (B)(6) 2024, THE SECOND SURGERY WAS PERFORMED FOR THE EXTENSION (L3/4/5.) DURING SURGERY, THE SURGEON CONFIRMED THAT THE SCREW AND THE SET SCREW ON L3 RIGHT WERE DISENGAGED. THE SURGEON DID NOT NOTICE IT ON THE PREOPERATIVE X-RAY IMAGE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS PC IS RELATED TO (B)(4) WHICH REPORTS INITIAL SURGERY TO THE SECOND SURGERY FOR THE EXTENSION. THIS PC REPORTS THE SCREW DISENGAGEMENT FOUND IN THE SECOND SURGERY. THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE UNITIZED SET SCR. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 20007352 ↗
• InjuryJun 12, 2024Break; Migration; Break; Migration

  IT WAS REPORTED A REVISION SURGERY OCCURRED ON (B)(6), 2024 DUE TO SCREW DISPLACEMENT AND MIGRATION. IN THE SURGERY, IT WAS CONFIRMED THAT SFX BROKE OFF AS WELL AS THE REPORTED SCREWS. THE DEVIATED SCREW WAS REPLACED. THE FENESTRATED SCREWS WERE ADDED FOR THE EXTENSION ON UPPER VERTEBRAE. ALL OF THE SET SCREW WERE REPLACED. SFX WAS PERFORMED. THE SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME WAS STABLE THE ORIGINAL SURGERY OCCURRED ON (B)(6) 2024 AND WAS FOR A SPINAL FUSION (L5/S) (L4-SAI FUSION USING VERSE), FOR PSEUDARTHROSIS ON MARCH 29, 2024. PATIENT WAS STABLE. ORIGINAL PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. IT WAS NOTED POST-OPERATIVELY ON AN UNKNOWN DATE THAT THE SCREWS HAD MIGRATED. THIS REPORT INVOLVES ONE (1) 5.5 EXP VERSE UNITIZED SET SCR THIS IS REPORT 6 OF 6 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19519218 ↗
• InjuryJun 12, 2024Break; Break

  IT WAS REPORTED A REVISION SURGERY OCCURRED ON (B)(6) 2024 DUE TO SCREW DISPLACEMENT AND MIGRATION. IN THE SURGERY, IT WAS CONFIRMED THAT SFX BROKE OFF AS WELL AS THE REPORTED SCREWS. THE DEVIATED SCREW WAS REPLACED. THE FENESTRATED SCREWS WERE ADDED FOR THE EXTENSION ON UPPER VERTEBRAE. ALL OF THE SET SCREW WERE REPLACED. SFX WAS PERFORMED. THE SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME WAS STABLE THE ORIGINAL SURGERY OCCURRED ON (B)(6) 2024 AND WAS FOR A SPINAL FUSION (L5/S) (L4-SAI FUSION USING VERSE), FOR PSEUDARTHROSIS ON (B)(6) 2024. PATIENT WAS STABLE. ORIGINAL PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. IT WAS NOTED POST-OPERATIVELY ON AN UNKNOWN DATE THAT THE SCREWS HAD MIGRATED. THIS REPORT INVOLVES ONE (1) 5.5 EXP VERSE UNITIZED SET SCR THIS IS REPORT 5 OF 6 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19519144 ↗
• InjuryJun 12, 2024Break; Migration; Break; Migration

  IT WAS REPORTED A REVISION SURGERY OCCURRED ON (B)(6) 2024 DUE TO SCREW DISPLACEMENT AND MIGRATION. IN THE SURGERY, IT WAS CONFIRMED THAT SFX BROKE OFF AS WELL AS THE REPORTED SCREWS. THE DEVIATED SCREW WAS REPLACED. THE FENESTRATED SCREWS WERE ADDED FOR THE EXTENSION ON UPPER VERTEBRAE. ALL OF THE SET SCREW WERE REPLACED. SFX WAS PERFORMED. THE SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME WAS STABLE THE ORIGINAL SURGERY OCCURRED ON (B)(6) 2024 AND WAS FOR A SPINAL FUSION (L5/S) (L4-SAI FUSION USING VERSE), FOR PSEUDARTHROSIS ON MARCH 29, 2024. PATIENT WAS STABLE. ORIGINAL PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. IT WAS NOTED POST-OPERATIVELY ON AN UNKNOWN DATE THAT THE SCREWS HAD MIGRATED. THIS REPORT INVOLVES ONE (1) 5.5 EXP VERSE UNITIZED SET SCR THIS IS REPORT 4 OF 6 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19519072 ↗
• InjuryJun 12, 2024Break; Migration; Break; Migration

  IT WAS REPORTED A REVISION SURGERY OCCURRED ON (B)(6) 2024 DUE TO SCREW DISPLACEMENT AND MIGRATION. IN THE SURGERY, IT WAS CONFIRMED THAT SFX BROKE OFF AS WELL AS THE REPORTED SCREWS. THE DEVIATED SCREW WAS REPLACED. THE FENESTRATED SCREWS WERE ADDED FOR THE EXTENSION ON UPPER VERTEBRAE. ALL OF THE SET SCREW WERE REPLACED. SFX WAS PERFORMED. THE SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME WAS STABLE THE ORIGINAL SURGERY OCCURRED ON (B)(6) 2024 AND WAS FOR A SPINAL FUSION (L5/S) (L4-SAI FUSION USING VERSE), FOR PSEUDARTHROSIS ON (B)(6) 2024. PATIENT WAS STABLE. ORIGINAL PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. IT WAS NOTED POST-OPERATIVELY ON AN UNKNOWN DATE THAT THE SCREWS HAD MIGRATED. THIS REPORT INVOLVES ONE (1) 5.5 EXP VERSE UNITIZED SET SCR THIS IS REPORT 1 OF 6 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19518314 ↗
• InjuryMar 6, 2024Migration; Migration

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT AN UNKNOWN SURGERY WAS PERFORMED ON (B)(6) 2024. L5/S FUSION, VERSE 1 INTERVERTEBRAL. THE CAGE IS A COMPETITOR¿S PRODUCT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER THE ORIGINAL PROCEDURE, ON (B)(6) 2024, THE SALES REP WAS INFORMED THAT THE SET SCREW IN QUESTION HAD BACKED OUT, AND THE L5 LEFT SET SCREW HAD COME OFF. THE CAUSE IS UNKNOWN, A REVISION PROCEDURE WAS SCHEDULED FOR (B)(6) 2024. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN EXPEDIUM VERSE SPINE SYSTEM UNITIZED SET SCREW. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18847999 ↗
• InjuryMar 1, 2024Migration; Migration

  DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, A REVISION SURGERY WAS PERFORMED TO REMOVE THE SET SCREW IN QUESTION. THE SCREW IN QUESTION HAD BACKED OUT. THE REMOVAL PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN EXPEDIUM VERSE SPINE SYSTEM UNITIZED SET SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18815980 ↗
• 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: OTHER, NON-UNION; COMPLICATION TIME/INTERVENTION; POSTOPERATIVE (BEFORE DISCHARGE), REPEAT SURGERY; THIS IS FOR DEPUY SYNTHES SPINE EXPEDIUM /OTHER AND VIPER /OTHER PRODUCTS. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

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

  MAUDE report 18467279 ↗
• InjuryJan 8, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  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: IMPLANT FAILURE COMPLICATION TIME/INTERVENTION REPEAT SURGERY THIS REPORT INVOLVES ONE EXPEDIUM VERSE SPINE SYSTEM UNITIZED SET SCREW. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18466243 ↗
• 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 UNITIZED SET SCREW THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: Joint Laxity

  MAUDE report 18465931 ↗