EXPEDIUM VERSE 199721645Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10705034442273), received between Aug 3, 2018 and Jan 22, 2024 — classified as 1 death, 9 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (10 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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 22, 2024Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT THE SCREW DID NOT ENGAGE WELL IN DRIVER. ANOTHER IMPLANT WAS USED AND THERE WAS NO DELAY. NO ISSUE FOR THE PATIENT AS PRODUCT WAS DISPOSED BY THE CLIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. THERE WERE NO PATIENT OUTCOME OR CONSEQUENCES. THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE SCREW 6.0 X 45 THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18551892 ↗
• 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. INTRAOPERATIVE, REPEAT SURGERY THIS IS FOR DEPUY SYNTHES SPINE EXPEDIUM /OTHER AND EXPEDIUM VERSE PRODUCTS (5.5 EXP VERSE SCREW 6.0 X 45 (B)(4).

  Patient problems: Bone Fracture(s); Joint Laxity

  MAUDE report 18445448 ↗
• MalfunctionJul 13, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM CHINA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE FOR LUMBAR SPONDYLOLISTHESIS ON (B)(6) 2022, AFTER THE VERSE SCREW WAS IMPLANTED, THE SCREW BECAME LOCKED AND COULD NOT BE ROTATED WHILE THE SCREW CAP WAS NOT FIXED. THE SURGEON REMOVED THE LOCKED SCREWS FROM THE PATIENT AND REPLACED THEM WITH DEVICES OF OTHER BRANDS TO COMPLETE THE PROCEDURE, PROLONGING THE SURGERY FOR APPROXIMATELY 3 HOURS. THERE IS NO PATIENT OUTCOME. THIS REPORT IS FOR A EXPEDIUM VERSE SPINE SYSTEM POLYAXIAL SCREW 5.5 6.0 X 45MM. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15007822 ↗
• MalfunctionJul 13, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM CHINA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE FOR LUMBAR SPONDYLOLISTHESIS ON (B)(6) 2022, AFTER THE VERSE SCREW WAS IMPLANTED, THE SCREW BECAME LOCKED AND COULD NOT BE ROTATED WHILE THE SCREW CAP WAS NOT FIXED. THE SURGEON REMOVED THE LOCKED SCREWS FROM THE PATIENT AND REPLACED THEM WITH DEVICES OF OTHER BRANDS TO COMPLETE THE PROCEDURE, PROLONGING THE SURGERY FOR APPROXIMATELY 3 HOURS. THERE IS NO PATIENT OUTCOME. THIS REPORT IS FOR A EXPEDIUM VERSE SPINE SYSTEM POLYAXIAL SCREW 5.5 6.0 X 45MM. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15007734 ↗
• MalfunctionJul 13, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM CHINA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE FOR LUMBAR SPONDYLOLISTHESIS ON (B)(6) 2022, AFTER THE VERSE SCREW WAS IMPLANTED, THE SCREW BECAME LOCKED AND COULD NOT BE ROTATED WHILE THE SCREW CAP WAS NOT FIXED. THE SURGEON REMOVED THE LOCKED SCREWS FROM THE PATIENT AND REPLACED THEM WITH DEVICES OF OTHER BRANDS TO COMPLETE THE PROCEDURE, PROLONGING THE SURGERY FOR APPROXIMATELY 3 HOURS. THERE IS NO PATIENT OUTCOME. THIS REPORT IS FOR A EXPEDIUM VERSE SPINE SYSTEM POLYAXIAL SCREW 5.5 6.0 X 45MM. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15007702 ↗
• InjuryJan 12, 2022Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PATIENT UNDERWENT THE REVISION PROCEDURE ON (B)(6) 2021 AS ONE (1) 5.5 EXP VERSE SCREW WAS NOT IN THE RIGHT PLACE AND IT WAS NECESSARY TO REPLACE IT. INITIAL SURGERY WAS PERFORMED AT END OF THE (B)(6) 2021, APPROXIMATELY 1 MONTH BEFORE THE REVISION SURGERY. THIS COMPLAINT IS RELATED TO COMPLAINT (B)(4) WHICH CAPTURES THE INTRA-OP EVENT. THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE SCREW 6.0 X 45. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

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

  MAUDE report 13239589 ↗
• MalfunctionJan 12, 2022Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES PORTUGAL REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED DURING A VERSE REVISION SURGERY, WHEN THE DOCTOR TRIED TO MOBILIZE THE HEAD OF THE SCREW, IT WAS NOT POSSIBLE BECAUSE IT WAS BLOCKED; EVEN WHEN USING THE HEAD ADJUSTER INSTRUMENT TO MOBILIZE THE HEAD. IT WAS NECESSARY TO TAKE OUT THE TWO SCREWS IN ORDER TO PLACE THE ROD. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A TEN (10) MINUTE DELAY AND CONSEQUENCE TO THE PATIENT. IT WAS NOTED THE REVISION PROCEDURE WAS NECESSARY DUE TO ONE OF THE SCREWS NOT BEING IN THE RIGHT PLACE. THE ORIGINAL PROCEDURE OCCURRED ABOUT A MONTH PRIOR IN NOVEMBER. THIS REPORT IS FOR AN EXPEDIUM VERSE SCREW. THIS IS REPORT 2 OF 2 FOR (B)(4). THIS COMPLAINT CAPTURES THE ISSUES DURING THE REVISION PROCEDURE. THE NEED FOR THE REVISION PROCEDURE IS CAPTURED IN RELATED COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13235737 ↗
• MalfunctionJan 12, 2022Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED DURING A VERSE REVISION SURGERY, WHEN THE DOCTOR TRIED TO MOBILIZE THE HEAD OF THE SCREW, IT WAS NOT POSSIBLE BECAUSE IT WAS BLOCKED; EVEN WHEN USING THE HEAD ADJUSTER INSTRUMENT TO MOBILIZE THE HEAD. IT WAS NECESSARY TO TAKE OUT THE TWO SCREWS IN ORDER TO PLACE THE ROD. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A TEN (10) MINUTE DELAY AND CONSEQUENCE TO THE PATIENT. IT WAS NOTED THE REVISION PROCEDURE WAS NECESSARY DUE TO ONE OF THE SCREWS NOT BEING IN THE RIGHT PLACE. THE ORIGINAL PROCEDURE OCCURRED ABOUT A MONTH PRIOR IN NOVEMBER. THIS REPORT IS FOR AN EXPEDIUM VERSE SCREW. THIS IS REPORT 1 OF 2 FOR (B)(4). THIS COMPLAINT CAPTURES THE ISSUES DURING THE REVISION PROCEDURE. THE NEED FOR THE REVISION PROCEDURE IS CAPTURED IN RELATED COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13235713 ↗
• InjuryJul 26, 2021Device Slipped; Device Slipped

  IT WAS REPORTED THAT ON (B)(6) 2021, THE SURGEON REVISED AN L4/5 FUSION. THE HARDWARE (EXPEDIUM VERSE & MATRIX X-LINK) WAS ALL LOSING DUE TO INFECTION AND NONUNION. ONE OF THE LOCK CAPS HAD COME OFF AS WELL. PATIENT AND PROCEDURE OUTCOME WERE UNKNOWN. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR (1) 5.5 EXP VERSE SCREW 7.0 X 45. THIS REPORT IS 2 OF 4 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12225014 ↗
• MalfunctionMar 31, 2021Crack; Crack

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, OF POSTERIOR LUMBAR INTERNAL FIXATION, WHEN FINAL TIGHTENED THE INNER SET SCREW, THE THREAD WAS PEELED. THE SURGEON ALSO REMOVED VERSE SCREW WHICH WAS CONNECT WITH THE INNER SET SCREW. IT WAS UNKNOWN IF THE SURGERY COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES ARE REPORTED. CONCOMITANT DEVICE REPORTED: UNKNOWN TIGHTENER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN ). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) 5.5 EXP VERSE SCREW 6.0 X 45. THIS REPORT IS 1 OF 2 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11599691 ↗
• MalfunctionJan 7, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN UNKNOWN PROCEDURE THE SCREW BROKE. THE SURGEON REMOVED THE BROKEN PIECE. THE SURGEON CONNECTED TWO SCREWS. PATIENT OUTCOME WAS UNKNOWN. THIS REPORT INVOLVES ONE (1) EXPEDIUM VERSE SPINE SYSTEM POLYAXIAL SCREW 5.5 6.0 X 45MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11131603 ↗
• MalfunctionDec 4, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 THE PATIENT UNDERWENT FOR AN UNKNOWN SURGERY. DURING THE SURGERY, THE SCREW HAS INNER THREAD DAMAGED DUE TO MULTIPLE TRYING TO ENGAGE CORRECTION KEY WHILE THE CORRECTION KEY HAS THE INNER GREY PART ISN¿T LOCKED. IT WAS UNKNOWN IF THE SURGERY COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME UNKNOWN. THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS REPORT IS FOR (1) 5.5 EXP VERSE SCREW 6.0 X 45. THIS REPORT IS 7 OF 7 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10945415 ↗
• MalfunctionDec 4, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 THE PATIENT UNDERWENT FOR AN UNKNOWN SURGERY. DURING THE SURGERY, THE SCREW HAS INNER THREAD DAMAGED DUE TO MULTIPLE TRYING TO ENGAGE CORRECTION KEY WHILE THE CORRECTION KEY HAS THE INNER GREY PART ISN¿T LOCKED. IT WAS UNKNOWN IF THE SURGERY COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME UNKNOWN. THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS REPORT IS FOR (1) 5.5 EXP VERSE SCREW 6.0 X 45. THIS REPORT IS 2 OF 7 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10945346 ↗
• MalfunctionSep 16, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, DURING A SPINE REVISION SURGERY, THE HEAD OF THE VERSE SCREWS DID NOT BECOME POLIAXIAL AND THE SCREWDRIVER COULD NOT BE INSERTED TO TAKE OUT THE SCREWS. THE LOCKING SCREWS AND RODS WERE REMOVED. ANOTHER INSTRUMENT WAS USED TO REMOVE TO REMOVE THE SCREWS. THERE WAS A SURGICAL DELAY OF TWENTY (20) MINUTES. NO FRAGMENTS WERE GENERATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO CONSEQUENCES TO THE PATIENT. CONCOMITANT DEVICE REPORTED: RODS (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN), LOCKING SCREW/ SET SCREW (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN), 5.5 EXP VERSE SCREW 6.0 X 45 (PART NUMBER 199721645, LOT 269766, QUANTITY 3), 5.5 EXP VERSE SCREW 6.0 X 45 (PART NUMBER 199721645, LOT 240964, QUANTITY 1), 5.5 EXP VERSE SCREW 6.0 X 40 (PART NUMBER 199721640, LOT 226103, QUANTITY 1), 5.5 EXP VERSE SCREW 6.0 X 40 (PART NUMBER 199721640, LOT 256371, QUANTITY 1), SCREWDRIVER (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) EXPEDIUM VERSE SPINE SYSTEM POLYAXIAL SCREW 5.5 6.0 X 45MM. THIS IS REPORT 5 OF 8 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10540295 ↗
• MalfunctionSep 16, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, DURING A SPINE REVISION SURGERY, THE HEAD OF THE VERSE SCREWS DID NOT BECOME POLIAXIAL AND THE SCREWDRIVER COULD NOT BE INSERTED TO TAKE OUT THE SCREWS. THE LOCKING SCREWS AND RODS WERE REMOVED. ANOTHER INSTRUMENT WAS USED TO REMOVE TO REMOVE THE SCREWS. THERE WAS A SURGICAL DELAY OF TWENTY (20) MINUTES. NO FRAGMENTS WERE GENERATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO CONSEQUENCES TO THE PATIENT. CONCOMITANT DEVICE REPORTED: RODS (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN), LOCKING SCREW/ SET SCREW (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN), 5.5 EXP VERSE SCREW 6.0 X 45 (PART NUMBER 199721645, LOT 269766, QUANTITY 2), 5.5 EXP VERSE SCREW 6.0 X 45 (PART NUMBER 199721645, LOT 218140, QUANTITY 1), 5.5 EXP VERSE SCREW 6.0 X 45 (PART NUMBER 199721645, LOT 240964, QUANTITY 1), 5.5 EXP VERSE SCREW 6.0 X 40 (PART NUMBER 199721640, LOT 226103, QUANTITY 1), 5.5 EXP VERSE SCREW 6.0 X 40 (PART NUMBER 199721640, LOT 256371, QUANTITY 1), SCREWDRIVER (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) EXPEDIUM VERSE SPINE SYSTEM POL

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10540290 ↗
• MalfunctionSep 16, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, DURING A SPINE REVISION SURGERY, THE HEAD OF THE VERSE SCREWS DID NOT BECOME POLIAXIAL AND THE SCREWDRIVER COULD NOT BE INSERTED TO TAKE OUT THE SCREWS. THE LOCKING SCREWS AND RODS WERE REMOVED. ANOTHER INSTRUMENT WAS USED TO REMOVE TO REMOVE THE SCREWS. THERE WAS A SURGICAL DELAY OF TWENTY (20) MINUTES. NO FRAGMENTS WERE GENERATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO CONSEQUENCES TO THE PATIENT. CONCOMITANT DEVICE REPORTED: RODS (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN), LOCKING SCREW/ SET SCREW (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN), 5.5 EXP VERSE SCREW 6.0 X 45 (PART NUMBER 199721645, LOT 269766, QUANTITY 3), 5.5 EXP VERSE SCREW 6.0 X 45 (PART NUMBER 199721645, LOT 218140, QUANTITY 1), 5.5 EXP VERSE SCREW 6.0 X 40 (PART NUMBER 199721640, LOT 226103, QUANTITY 1), 5.5 EXP VERSE SCREW 6.0 X 40 (PART NUMBER 199721640, LOT 256371, QUANTITY 1), SCREWDRIVER (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) EXPEDIUM VERSE SPINE SYSTEM POLYAXIAL SCREW 5.5 6.0 X 45MM. THIS IS REPORT 6 OF 8 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10539627 ↗
• MalfunctionSep 15, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, DURING A SPINE REVISION SURGERY, THE HEAD OF THE VERSE SCREWS DID NOT BECOME POLIAXIAL, AND THE SCREWDRIVER COULD NOT BE INSERTED TO TAKE OUT THE SCREWS. THE LOCKING SCREWS AND RODS WERE REMOVED. ANOTHER INSTRUMENT WAS USED TO REMOVE TO REMOVE THE SCREWS. THERE WAS A SURGICAL DELAY OF TWENTY (20) MINUTES. NO FRAGMENTS WERE GENERATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO CONSEQUENCES TO THE PATIENT. CONCOMITANT DEVICE REPORTED: RODS (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN), LOCKING SCREW/ SET SCREW (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN), 5.5 EXP VERSE SCREW 6.0 X 45 (PART NUMBER 199721645, LOT 269766, QUANTITY 2), 5.5 EXP VERSE SCREW 6.0 X 45 (PART NUMBER 199721645, LOT 218140, QUANTITY 1), 5.5 EXP VERSE SCREW 6.0 X 45 (PART NUMBER 199721645, LOT 240964, QUANTITY 1), 5.5 EXP VERSE SCREW 6.0 X 45 (PART NUMBER 199721645, LOT 226103, QUANTITY 1), 5.5 EXP VERSE SCREW 6.0 X 45 (PART NUMBER 199721645, LOT 256371, QUANTITY 1), SCREWDRIVER (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) EXPEDIUM VERSE SPINE SYSTEM PO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10536451 ↗
• MalfunctionSep 15, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, DURING A SPINE REVISION SURGERY, THE HEAD OF THE VERSE SCREWS DID NOT BECOME POLIAXIAL, AND THE SCREWDRIVER COULD NOT BE INSERTED TO TAKE OUT THE SCREWS. THE LOCKING SCREWS AND RODS WERE REMOVED. ANOTHER INSTRUMENT WAS USED TO REMOVE TO REMOVE THE SCREWS. THERE WAS A SURGICAL DELAY OF TWENTY (20) MINUTES. NO FRAGMENTS WERE GENERATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO CONSEQUENCES TO THE PATIENT. CONCOMITANT DEVICE REPORTED: RODS (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN), LOCKING SCREW/ SET SCREW (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN), 5.5 EXP VERSE SCREW 6.0 X 45 (PART NUMBER 199721645, LOT 269766, QUANTITY 2), 5.5 EXP VERSE SCREW 6.0 X 45 (PART NUMBER 199721645, LOT 218140, QUANTITY 1), 5.5 EXP VERSE SCREW 6.0 X 45 (PART NUMBER 199721645, LOT 240964, QUANTITY 1), 5.5 EXP VERSE SCREW 6.0 X 45 (PART NUMBER 199721645, LOT 226103, QUANTITY 1), 5.5 EXP VERSE SCREW 6.0 X 45 (PART NUMBER 199721645, LOT 256371, QUANTITY 1), SCREWDRIVER (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) EXPEDIUM VERSE SPINE SYSTEM PO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10536409 ↗
• InjurySep 15, 2020Unintended Movement; Unintended Movement

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, A REVISION SURGERY WAS DONE BECAUSE THE PATIENT HAD SYMPTOMS OF BACK AND LEG PAIN AND IT WAS NECESSARY MORE DECOMPRESSION. DURING SURGERY WAS DETECTED THAT SOME SCREWS DIDN¿T HAD FIXATION, THEY WERE LOOSE. IT WAS ONLY IN THE BEGINNING OF THE SURGERY THAT SURGEON CONFIRM THAT SOME SCREWS WERE LOOSE. IT WAS UNKNOWN IF THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN RODS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN ); UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN ). THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS REPORT IS FOR (1) 5.5 EXP VERSE SCREW 6.0 X 45. THIS IS REPORT 1 OF 7 (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 10535691 ↗
• InjurySep 15, 2020Unintended Movement; Unintended Movement

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, A REVISION SURGERY WAS DONE BECAUSE THE PATIENT HAD SYMPTOMS OF BACK AND LEG PAIN AND IT WAS NECESSARY MORE DECOMPRESSION. DURING SURGERY WAS DETECTED THAT SOME SCREWS DIDN¿T HAD FIXATION, THEY WERE LOOSE. IT WAS ONLY IN THE BEGINNING OF THE SURGERY THAT SURGEON CONFIRM THAT SOME SCREWS WERE LOOSE. IT WAS UNKNOWN IF THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN RODS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN ); UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN ). THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS REPORT IS FOR (1) 5.5 EXP VERSE SCREW 6.0 X 45. THIS IS REPORT 3 OF 7 (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 10535687 ↗
• InjurySep 15, 2020Unintended Movement; Unintended Movement

  DEVICE REPORT FROM (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, A REVISION SURGERY WAS DONE BECAUSE THE PATIENT HAD SYMPTOMS OF BACK AND LEG PAIN AND IT WAS NECESSARY MORE DECOMPRESSION. DURING SURGERY WAS DETECTED THAT SOME SCREWS DIDN'T HAD FIXATION, THEY WERE LOOSE. IT WAS ONLY IN THE BEGINNING OF THE SURGERY THAT SURGEON CONFIRM THAT SOME SCREWS WERE LOOSE. IT WAS UNKNOWN IF THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN RODS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN ), UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN ). THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS REPORT IS FOR (1) 5.5 EXP VERSE SCREW 6.0 X 45. (B)(6).

  Patient problems: No Code Available; Pain

  MAUDE report 10535684 ↗
• InjurySep 15, 2020Unintended Movement; Unintended Movement

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, A REVISION SURGERY WAS DONE BECAUSE THE PATIENT HAD SYMPTOMS OF BACK AND LEG PAIN AND IT WAS NECESSARY MORE DECOMPRESSION. DURING SURGERY WAS DETECTED THAT SOME SCREWS DIDN¿T HAD FIXATION, THEY WERE LOOSE. IT WAS ONLY IN THE BEGINNING OF THE SURGERY THAT SURGEON CONFIRM THAT SOME SCREWS WERE LOOSE. IT WAS UNKNOWN IF THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN RODS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN ); UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN ). THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS REPORT IS FOR (1) 5.5 EXP VERSE SCREW 6.0 X 45. THIS IS REPORT 6 OF 7 (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 10535680 ↗
• InjurySep 15, 2020Unintended Movement; Unintended Movement

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, A REVISION SURGERY WAS DONE BECAUSE THE PATIENT HAD SYMPTOMS OF BACK AND LEG PAIN AND IT WAS NECESSARY MORE DECOMPRESSION. DURING SURGERY WAS DETECTED THAT SOME SCREWS DIDN¿T HAD FIXATION, THEY WERE LOOSE. IT WAS ONLY IN THE BEGINNING OF THE SURGERY THAT SURGEON CONFIRM THAT SOME SCREWS WERE LOOSE. IT WAS UNKNOWN IF THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN RODS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN ). UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN ). THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS REPORT IS FOR (1) 5.5 EXP VERSE SCREW 6.0 X 45. THIS IS REPORT 7 OF 7 (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 10535672 ↗
• MalfunctionAug 13, 2019Material Deformation; Material Deformation

  L5-S1 POSTERIOR STABILIZATION: (B)(6) HOSPITAL, (B)(6) 2019. PATIENT CAME IN TO GET POSTERIOR STABILIZATION (DOS (B)(6) 2019) AFTER HAVING AN ALIF IN 2015. PATIENT HAD A SMALL SPONDI (SLIPPAGE OF L5 OVER S1). THE SLIPPAGE BROKE THE TWO LOWER SCREWS RATHER THAN PULLED THEM OUT. IT IS THOUGHT THE PATIENT FUSED WITH SLIPPAGE. SURGEON ATTEMPTED TO CORRECT SPONDY (ALIGNMENT) WITH VERSE TECHNOLOGY, BUT GIVEN SHORT ROD, SCREW APPEARED TO BE BENT AT WEAKEST/THINNEST POINT (BETWEEN THREADS AND TULIP HEAD). SURGEON REMOVED SCREW AND UPSIZED, LOCKED DOWN AND CLOSED. PATIENT OUTCOME:NO DEVIATION FROM INITIAL PLAN OTHER THAN THE EXCHANGE OF ONE SCREW FOR ANOTHER. ACTION TAKEN:REPLACING ONE SCREW FOR ANOTHER (LARGER DIAMETER) SCREW. PATIENT AGE:(B)(6). DOB:(B)(6). THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8887588 ↗
• DeathMay 9, 2019Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IN THE PROCESS OF INSERTING THE ROD INTO THE SCREW HEAD, BY USING A "QUICK STICK"- A SORT OF PERSUADER, THE SURGEON APPLIED EXTREME FORCE THAT BROKE ON THE SCREW`S "WINGS". THOSE WINGS ARE MEANT TO BE BROKEN IN THE END OF THE SURGERY BUT IN THAT CASE, APPARENTLY SOME OF THE SCREW HEAD`S TULIP WAS BROKEN AS WELL AND WAS TAKEN OUT OF THE WOUND. AFTER A FEW MINUTES, WHILE TRYING TO INSERT THE SCREW INNIE (AKA SET SCREW) TO THE HEAD OF THE SCREW, THE SURGEONS SAW THAT THE TULIP OF THE SCREWS WERE NOT EQUAL AND THAT THE INNIE IS PARTLY OUT OF THE SCREW HEAD. THAT'S WHEN THEY REALIZED THAT THE TIP THAT WAS BROKEN BELONGS TO THAT SPECIFIC SCREW, THEY HAVE DECIDED TO SKIP PUTTING AN INNIE IN THAT SPECIFIC SCREW SO THAT THEY ARE SURE THAT ALL THE INNIES ARE SAFELY LOCKED TO ALL THE SCREW. SINCE THEY HAD A GOOD FIXATION IN THE OTHER SCREWS, THEY FELT SAFE TO SKIP THAT INNIE. NO DAMAGE WAS CAUSED TO THE PATIENT AND NO ADDITIONAL TIME OF HOSPITALIZATION WAS REQUIRED.

  Patient problems: Death; No Code Available

  MAUDE report 8596143 ↗