EXPEDIUM VERSE 199721001Recalls & reported problems

Summary

The FDA's MAUDE database contains 227 adverse event reports that list this exact device (DI 10705034466156), received between Aug 3, 2017 and Feb 25, 2025 — classified as 189 injuries, 38 malfunctions.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (50 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 227 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 25, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AUGUST 29, 2024, DURING THE PROCEDURE, THERE WERE PROBLEMS FOR THE LOCKING SCREWS WORKING BECAUSE THEY DID NOT BLOCK THE BAR AFTER PERFORMING THE CORRECTION REQUIRED BY THE SPECIALIST. THIS CAUSED THE DAMAGED LOCKING SCREWS AND THE TRANSPEDICULAR SCREWS WITH DAMAGED THREADS TO BE REPLACED. THREE (3) 5.5 EXP VERSE SCREW 6.0 X 55 AND ONE (1) 5.5 EXP VERSE SCREW 6.0 X 40 SCREWS WERE DAMAGED DUE TO CLOSING SCREWS IN BAD SHAPE. SIX (6) VERSE CORRECTION KEYS DIDN'T BLOCK THE BAR AND IN THE END THE SCREW WERE DAMAGED AND TWO (2) 5.5 EXP VERSE UNITIZED SET SCREWS WERE ALREADY DAMAGED AND AS THEY WERE BEING TIGHTENED, THE THREADS OF THE SCREWS BECAME FURTHER DAMAGED. THIS AFFECTED THE SURGICAL TIME, EXTENDING THE TIME BY APPROXIMATELY ONE (1) HOUR. THE ISSUE ALSO AFFECTED THE PATIENT BECAUSE MORE ANESTHESIA TIME WAS REQUIRED. THIS COMPLAINT IS RELATED TO (B)(4) WHICH REPORTS ADDITIONAL IMPACTED DEVICES.

  Patient problems: Insufficient Information

  MAUDE report 21461002 ↗
• MalfunctionSep 16, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2024, DURING THE PROCEDURE, THERE WERE PROBLEMS FOR THE LOCKING SCREWS WORKING BECAUSE THEY DID NOT BLOCK THE BAR AFTER PERFORMING THE CORRECTION REQUIRED BY THE SPECIALIST. THIS CAUSED THE DAMAGED LOCKING SCREWS AND THE TRANSPEDICULAR SCREWS WITH DAMAGED THREADS TO BE REPLACED. THIS AFFECTED THE SURGICAL TIME, EXTENDING THE TIME BY APPROXIMATELY ONE (1) HOUR. THE ISSUE ALSO AFFECTED THE PATIENT BECAUSE MORE ANESTHESIA TIME WAS REQUIRED.

  Patient problems: Insufficient Information

  MAUDE report 20224690 ↗
• InjuryJul 18, 2024Device Slipped; Device Slipped

  IT WAS REPORTED THAT THIS WAS A POSTERIOR SPINAL FUSION (L2) PERFORMED ON (B)(6)2023, WITH VBS+VERSE. THREE MONTHS AFTER SURGERY, IT WAS INSTALLED WITHOUT PROBLEMS. SIX MONTHS POSTOPERATIVELY, BREAKAGE OF THE SCREW IN QUESTION AND LOOSENING OF THE CONTRALATERAL SET SCREW WERE OBSERVED. ON (B)(6) 2024, THE SECOND SURGERY WAS PERFORMED TO REMOVE THE SCREW AND THE SET SCREW. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE UNITIZED SET SCR THIS IS REPORT 7 OF 9 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19770334 ↗
• InjuryJul 16, 2024Device Slipped; Device Slipped

  IT WAS REPORTED THAT THIS WAS A POSTERIOR SPINAL FUSION (L2) PERFORMED ON (B)(6) 2023, WITH VBS+VERSE. THREE MONTHS AFTER SURGERY, IT WAS INSTALLED WITHOUT PROBLEMS. SIX MONTHS POSTOPERATIVELY, BREAKAGE OF THE SCREW IN QUESTION AND LOOSENING OF THE CONTRALATERAL SET SCREW WERE OBSERVED. ON (B)(6) 2024, THE SECOND SURGERY WAS PERFORMED TO REMOVE THE SCREW AND THE SET SCREW. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE UNITIZED SET SCR THIS IS REPORT 9 OF 9 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19757294 ↗
• InjuryJul 16, 2024Device Slipped; Device Slipped

  IT WAS REPORTED THAT THIS WAS A POSTERIOR SPINAL FUSION (L2) PERFORMED ON (B)(6) 2023, WITH VBS+VERSE. THREE MONTHS AFTER SURGERY, IT WAS INSTALLED WITHOUT PROBLEMS. SIX MONTHS POSTOPERATIVELY, BREAKAGE OF THE SCREW IN QUESTION AND LOOSENING OF THE CONTRALATERAL SET SCREW WERE OBSERVED. ON (B)(6) 2024, THE SECOND SURGERY WAS PERFORMED TO REMOVE THE SCREW AND THE SET SCREW. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE UNITIZED SET SCR THIS IS REPORT 8 OF 9 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19757277 ↗
• InjuryJul 16, 2024Device Slipped; Device Slipped

  IT WAS REPORTED THAT THIS WAS A POSTERIOR SPINAL FUSION (L2) PERFORMED ON (B)(6) 2023, WITH VBS+VERSE. THREE MONTHS AFTER SURGERY, IT WAS INSTALLED WITHOUT PROBLEMS. SIX MONTHS POSTOPERATIVELY, BREAKAGE OF THE SCREW IN QUESTION AND LOOSENING OF THE CONTRALATERAL SET SCREW WERE OBSERVED. ON (B)(6) 2024, THE SECOND SURGERY WAS PERFORMED TO REMOVE THE SCREW AND THE SET SCREW. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE UNITIZED SET SCR THIS IS REPORT 6 OF 9 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19757274 ↗
• InjuryJul 16, 2024Device Slipped; Device Slipped

  IT WAS REPORTED THAT THIS WAS A POSTERIOR SPINAL FUSION (L2) PERFORMED ON (B)(6) 2023, WITH VBS+VERSE. THREE MONTHS AFTER SURGERY, IT WAS INSTALLED WITHOUT PROBLEMS. SIX MONTHS POSTOPERATIVELY, BREAKAGE OF THE SCREW IN QUESTION AND LOOSENING OF THE CONTRALATERAL SET SCREW WERE OBSERVED. ON (B)(6) 2024, THE SECOND SURGERY WAS PERFORMED TO REMOVE THE SCREW AND THE SET SCREW. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE UNITIZED SET SCR THIS IS REPORT 5 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19755431 ↗
• InjuryJul 16, 2024Device Slipped; Device Slipped

  IT WAS REPORTED THAT THIS WAS A POSTERIOR SPINAL FUSION (L2) PERFORMED ON (B)(6) 2023, WITH VBS+VERSE. THREE MONTHS AFTER SURGERY, IT WAS INSTALLED WITHOUT PROBLEMS. SIX MONTHS POSTOPERATIVELY, BREAKAGE OF THE SCREW IN QUESTION AND LOOSENING OF THE CONTRALATERAL SET SCREW WERE OBSERVED. ON (B)(6) 2024, THE SECOND SURGERY WAS PERFORMED TO REMOVE THE SCREW AND THE SET SCREW. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE UNITIZED SET SCR THIS IS REPORT 2 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19755009 ↗
• MalfunctionMay 15, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A SPINAL FUSION (L4-S1 POSTERIOR LUMBAR FUSION) THE SURGEON WAS USING THE EXPEDIUM SI FINAL TIGHTENER WITH TORQUE HANDLE TO LOCK OFF THE SETS SCREW ON THE CONSTRUCT. BOTH SET SCREWS GOT STRIPPED. REPLACED WITH NEW SET SCREWS AND LOCKED THE CONSTRUCT OFF WITH THE PROPER EXPEDIUM VERSE FINAL TIGHTENER AND TORQUE HANDLE IN SET. THERE WAS NO SURGICAL DEALY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THE SALES REPRESENTATIVE HAS SPOKEN TO SURGEON REGARDING THE USE OF THE CORRECT INSTRUMENT. THE TIP OF THE EXPEDIUM SI DESPUTE BEING BOTH X25 DRIVERS, ARE MORE SHALLOW HENCE WHY THE DRIVER WILL NOT ENGAGE WITH THE SET SCREW AS WELL AS THE PROPER EXPEDIUM VERSE X25 DRIVER. MORE CHANCE OF THE EXPEDIUM SI DRIVER NOT ENGAGING INTO THE SET SCREWS AND STRIPS IT DOWN. THIS REPORT INVOLVES ONE (1) EXPEDIUM VERSE SPINE SYSTEM UNITIZED SET SCREW 5.5. THIS IS REPORT 3 OF 3 FOR PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19324122 ↗
• MalfunctionMay 15, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A SPINAL FUSION (L4-S1 POSTERIOR LUMBAR FUSION) THE SURGEON WAS USING THE EXPEDIUM SI FINAL TIGHTENER WITH TORQUE HANDLE TO LOCK OFF THE SETS SCREW ON THE CONSTRUCT. BOTH SET SCREWS GOT STRIPPED. REPLACED WITH NEW SET SCREWS AND LOCKED THE CONSTRUCT OFF WITH THE PROPER EXPEDIUM VERSE FINAL TIGHTENER AND TORQUE HANDLE IN SET. THERE WAS NO SURGICAL DELAY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THE SALES REPRESENTATIVE HAS SPOKEN TO SURGEON REGARDING THE USE OF THE CORRECT INSTRUMENT. THE TIP OF THE EXPEDIUM SI DESPITE BEING BOTH X25 DRIVERS, ARE MORE SHALLOW HENCE WHY THE DRIVER WILL NOT ENGAGE WITH THE SET SCREW AS WELL AS THE PROPER EXPEDIUM VERSE X25 DRIVER. MORE CHANCE OF THE EXPEDIUM SI DRIVER NOT ENGAGING INTO THE SET SCREWS AND STRIPS IT DOWN. THIS REPORT INVOLVES ONE (1) EXPEDIUM VERSE SPINE SYSTEM UNITIZED SET SCREW 5.5. THIS IS REPORT 2 OF 3 FOR (B)(4)..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19324117 ↗
• 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 HEMATOMA, ADJACENT SEGMENT PATHOLOGY, INSTABILITY COMPLICATION TIME/INTERVENTION POSTOPERATIVE (BEFORE DISCHARGE), REPEAT SURGERY THIS IS FOR DEPUY SYNTHES SPINE EXPEDIUM /OTHER ,EXPEDIUM VERSE FENESTRATED ,MOSS MIAMI SI /OTHER AND VIPER CFX FENESTRATED PRODUCTS THIS IS REPORT 1 OF 6 FOR COMPLAINT (B)(4)

  Patient problems: Hematoma; Joint Laxity; Osteolysis

  MAUDE report 18465130 ↗
• 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: NEUROCOMPRESSION COMPLICATION TIME/INTERVENTION REPEAT SURGERY THIS REPORT INVOLVES ONE EXPEDIUM VERSE SPINE SYSTEM UNITIZED SET SCREW 5.5 THIS IS REPORT 1 OF 6 FOR (B)(4).

  Patient problems: Nerve Damage

  MAUDE report 18462963 ↗
• InjuryJan 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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: NEUROCOMPRESSION, NON-UNION. COMPLICATION TIME/INTERVENTION. REPEAT SURGERY. THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE UNITIZED SET SCR. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Nerve Damage; Nonunion/Delayed-union Bone Fracture

  MAUDE report 18447535 ↗
• InjuryJan 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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: FRACTURE VERTEBRAL STRUCTURES, INSTABILITY, COMPLICATION TIME/INTERVENTION, AND INTRAOPERATIVE, REPEAT SURGERY. THIS IS FOR DEPUY SYNTHES SPINE EXPEDIUM /OTHER AND EXPEDIUM VERSE PRODUCTS (5.5 EXP VERSE UNITIZED SET SCR (B)(4).

  Patient problems: Bone Fracture(s); Joint Laxity

  MAUDE report 18445166 ↗
• InjuryNov 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY WAS COMPLETED SUCCESSFULLY. IT WAS FURTHER REPORTED BROKEN FRAGMENTS REMAINED IN THE PATIENT. NO ADDITIONAL INTERVENTION WAS USED TO REMOVE THE FRAGMENTS. PATIENT STATUS IS UNKNOWN. (B)(4) IS LINKED TO (B)(4) TO CAPTURE ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: Unspecified Infection

  MAUDE report 18182410 ↗
• InjuryNov 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY WAS COMPLETED SUCCESSFULLY. IT WAS FURTHER REPORTED BROKEN FRAGMENTS REMAINED IN THE PATIENT. NO ADDITIONAL INTERVENTION WAS USED TO REMOVE THE FRAGMENTS. PATIENT STATUS IS UNKNOWN. (B)(4) IS LINKED TO (B)(4) TO CAPTURE ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: Unspecified Infection

  MAUDE report 18182393 ↗
• InjuryNov 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY WAS COMPLETED SUCCESSFULLY. IT WAS FURTHER REPORTED BROKEN FRAGMENTS REMAINED IN THE PATIENT. NO ADDITIONAL INTERVENTION WAS USED TO REMOVE THE FRAGMENTS. PATIENT STATUS IS UNKNOWN. (B)(4) IS LINKED TO (B)(4) TO CAPTURE ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: Unspecified Infection

  MAUDE report 18182373 ↗
• InjuryNov 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY WAS COMPLETED SUCCESSFULLY. IT WAS FURTHER REPORTED BROKEN FRAGMENTS REMAINED IN THE PATIENT. NO ADDITIONAL INTERVENTION WAS USED TO REMOVE THE FRAGMENTS. PATIENT STATUS IS UNKNOWN. (B)(4) IS LINKED TO (B)(4) TO CAPTURE ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: Unspecified Infection

  MAUDE report 18182366 ↗
• InjuryNov 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY WAS COMPLETED SUCCESSFULLY. IT WAS FURTHER REPORTED, BROKEN FRAGMENTS REMAINED IN THE PATIENT. NO ADDITIONAL, INTERVENTION WAS USED TO REMOVE THE FRAGMENTS. PATIENT STATUS IS UNKNOWN. (B)(4) IS LINKED TO (B)(4) TO CAPTURE ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: Unspecified Infection

  MAUDE report 18182363 ↗
• InjuryNov 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY WAS COMPLETED SUCCESSFULLY. IT WAS FURTHER REPORTED BROKEN FRAGMENTS REMAINED IN THE PATIENT. NO ADDITIONAL INTERVENTION WAS USED TO REMOVE THE FRAGMENTS. PATIENT STATUS IS UNKNOWN. (B)(4) IS LINKED TO (B)(4) TO CAPTURE ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: Unspecified Infection

  MAUDE report 18182360 ↗
• InjuryNov 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY WAS COMPLETED SUCCESSFULLY. IT WAS FURTHER REPORTED BROKEN FRAGMENTS REMAINED IN THE PATIENT. NO ADDITIONAL INTERVENTION WAS USED TO REMOVE THE FRAGMENTS. PATIENT STATUS IS UNKNOWN. (B)(4) IS LINKED TO (B)(4) TO CAPTURE ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: Unspecified Infection

  MAUDE report 18182355 ↗
• InjuryNov 21, 2023Break; Entrapment of Device; Break; Entrapment of Device

  REVISION SURGERY WAS COMPLETED SUCCESSFULLY. IT WAS FURTHER REPORTED BROKEN FRAGMENTS REMAINED IN THE PATIENT. NO ADDITIONAL INTERVENTION WAS USED TO REMOVE THE FRAGMENTS. PATIENT STATUS IS UNKNOWN. (B)(4) IS LINKED TO (B)(4) TO CAPTURE ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: Foreign Body In Patient; Unspecified Infection

  MAUDE report 18182350 ↗
• InjuryMay 31, 2023Device Slipped; Device Slipped

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE AND MONTH IN 2023, A UNITIZED SET SCREW HAS COME LOOSE OFF A SINGLE LEVEL PLIF. THE PRIMARY SURGERY WAS (B)(6) 2023. THE PATIENT EXPERIENCE AN ADVERSE EVENT AND HAS DEVELOPED BACK PAIN. THIS REPORT IS FOR ONE (1) EXPEDIUM VERSE SPINE SYSTEM UNITIZED SET SCREW 5.5. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Pain

  MAUDE report 17032945 ↗
• InjuryMay 31, 2023Device Slipped; Device Slipped

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT A UNITIZED SET SCREW HAS COME LOOSE OFF A SINGLE LEVEL PLIF. THE PRIMARY SURGERY WAS ON (B)(6) 2023. THE PATIENT EXPERIENCE AN ADVERSE EVENT AND HAS DEVELOPED BACK PAIN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE UNITIZED SET SCR. THIS IS REPORT 1 OF 1 FOR COMPLAINT: (B)(4).

  Patient problems: Pain

  MAUDE report 17031692 ↗
• MalfunctionApr 12, 2023Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN BRAZIL AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT DURING THE PROCEDURE, IT WAS IDENTIFIED BY THE INSTRUMENT AND COMMERCIAL REPRESENTATIVE OF VERTICAL DF (DISTRIBUTOR), THAT THE POLYAXIAL SCREW BLOCKER WAS NOT HOLDING THE TORQUE GIVEN BY THE SURGEON AND ENDED UP DAMAGING THE SCREW THREAD AND THREE BLOCKERS. REF: (B)(4). DESCRIPTION: EXPEDIUM VERSE KEY CONNECTOR. IT HAS BEEN INFORMED BY THE REPRESENTATIVE THAT IT IS THE SECOND OCCURRENCE RELATED TO THIS PRODUCT THAT IS IDENTIFIED DURING THE PROCEDURE. THIS COMPLAINT CAPTURES THE FIRST EVENT THAT OCCURRED. THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE UNITIZED SET SCR. THIS IS REPORT 1 OF 2 FOR COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16724722 ↗