EXPEDIUM VERSE 199723745SRecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10705034444505), received between Aug 7, 2018 and Aug 5, 2026 — classified as 13 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Break” (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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• 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 50147954 ↗
• 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 50147862 ↗
• MalfunctionNov 14, 2025Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT A POSTERIOR FUSION (T12) FOR RESIDUAL SCOLIOSIS ON (B)(6) 2025. DURING THE PROCEDURE, THE SCREWHEAD BROKE OFF BY A FEW MILLIMETERS DURING THE FINAL TORQUE TIGHTENING. THE SURGEON DETERMINED THAT THE SETSCREW HAD BEEN PLACED AND THE ROD HAD BEEN FIXED PROPERLY, SO THE WOUND WAS CLOSED AFTER FINAL TIGHTENING. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23554451 ↗
• MalfunctionAug 2, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT AN INITIAL SURGERY (L1/2/3) PERFORMED ON (B)(6) 2022 WITH VERSE FENESTRATED SYSTEM. AFTER THE SURGERY, ADJACENT INTERVERTEBRAL DISORDERS WAS CONFIRMED. ON (B)(6) 2024, THE EXTENSION SURGERY TO L4 WAS PERFORMED. BEFORE THE SURGERY, THERE WERE NO FRACTURE REPORTS, NO IMAGING FINDINGS, NO PATIENT REPORTS, ETC. CEMENT HAD BEEN INJECTED. IN THE SURGERY, THE SET SCREW AND ROD WERE REMOVED. WHEN THE L3 SCREWS IN QUESTION WAS PULLED OUT WITH A CORE SCREWDRIVER TO CHECK FOR LOOSENING OF THE SCREW AS PER THE PROCEDURE MANUAL, BREAKAGE WAS CONFIRMED AROUND 5 MM FROM THE TIP OF THE SCREW INSERTED IN L3. THE TIP WAS BROKEN BY AIR TOMING FROM THE EXTRACTION SITE, AND A NEW SCREW WAS REINSERTED AND FIXED. THE BROKEN FRAGMENTS REMAIN IN THE VERTEBRAL BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 30 MINUTES SURGICAL DELAY. THIS (B)(4) IS RELATED TO (B)(4) WHICH REPORTS AN ADJACENT INTERVERTEBRAL DISORDERS CONFIRMED AFTER THE INITIAL SURGERY. THIS (B)(4) REPORTS THE SCREW BREAKAGE AND DIFFICULTY OF REMOVING THE SCREW OCCURRED IN THE SECOND SURGERY. THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE FEN SCR 7.0X45. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 19899385 ↗
• 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 45MM THIS IS REPORT 3 OF 5 FOR (B)(4).

  Patient problems: Joint Laxity

  MAUDE report 18465926 ↗
• InjuryJan 5, 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: NON-UNION, COMPLICATION TIME/INTERVENTION, REPEAT SURGERY, THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE FEN SCR 7.0X45, THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 18454953 ↗
• 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: NEUROCOMPRESSION COMPLICATION TIME/INTERVENTION REPEAT SURGERY THIS IS FOR DEPUY SYNTHES SPINE EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 7.0 X 45MM THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: Nerve Damage

  MAUDE report 18453813 ↗
• MalfunctionDec 20, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A POSTERIOR LUMBAR SPINAL FUSION ON (B)(6) 2023. THE SCREW IN QUESTION AND 0.1 ML OF THE CEMENT WAS USED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THERE WERE NO PROBLEMS WITH FOLLOW-UP. ON (B)(6) 2023, X-RAY SHOWED A BROKEN SCREW. REVISION SURGERY IS NOT PLANNED AT THIS MOMENT. THIS REPORT INVOLVES ONE EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 7.0 X 45MM. THIS REPORT IS RELATED TO (B)(4), WHICH REPORTS THE INVOLVED CEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18367066 ↗
• MalfunctionOct 10, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A SPINAL FUSION OF THE THORACOLUMBAR SPINE (TH10-L4) FOR A L1 OVF ON (B)(6) 2023. PLANNED SCREWS WERE INSERTED INTO THE PLANNED RANGE, CEMENT WAS INJECTED INTO THE SCREW AT TH10/L3, AND AN ALIGNMENT DEVICE AT THE L3 LEFT WAS REMOVED AFTER FINISHING CEMENT INJECTION. WHEN THE SURGEON REMOVED THE ALIGNMENT DEVICE, THE EXPEDIUM VERSE FENESTRATED SCREW GOT CAUGHT IN IT AND CAME OUT ALONG WITH IT. SINCE THE INJECTED CEMENT WAS REMAINED INSIDE THE VERTEBRAL BODY, THE SURGEON IMMEDIATELY INSERTED A VIPER-PRIME SCREW WITH THE SAME SIZE. AFTER THAT, THERE WAS NO PARTICULAR PROBLEMS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. PATIENT STATUS/ OUTCOME: STABLE. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN BIOMATERIAL - CEMENT (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN) UNKNOWN ALIGNMENT DEVICE (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE FEN SCR 7.0X45 THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17905512 ↗
• MalfunctionJul 12, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT DURING A PLANNED SECOND SPINAL SURGERY (T12-L3) ON (B)(6) 2023, WHEN ATTEMPTING TO CONNECT T12-L3, THE LOCKS OF THE HEADS OF THE VERSE FENESTRATED SCREWS WERE NOT RELEASED, AND THE CONNECTION USING RODS COULD NOT BE APPLIED. THE FENESTRATED SCREWS HAD BEEN IMPLANTED IN THE FIRST SURGERY ON (B)(6) 2023. THERE WERE FOUR PLACES WHERE THE LOCKS OF THE HEADS OF THE VERSE FENESTRATED SCREWS HAD TO BE RELEASED, THEREFORE THE FOUR SCREWS WERE REPLACED WITH SIZED-UP ONES, AND THE CONNECTION USING RODS WAS DONE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THIS REPORT INVOLVES ONE EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 7.0 X 45MM. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17304927 ↗
• MalfunctionJul 12, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT DURING A PLANNED SECOND SPINAL SURGERY (T12-L3) ON (B)(6) 2023, WHEN ATTEMPTING TO CONNECT T12-L3, THE LOCKS OF THE HEADS OF THE VERSE FENESTRATED SCREWS WERE NOT RELEASED, AND THE CONNECTION USING RODS COULD NOT BE APPLIED. THE FENESTRATED SCREWS HAD BEEN IMPLANTED IN THE FIRST SURGERY ON (B)(6) 2023. THERE WERE FOUR PLACES WHERE THE LOCKS OF THE HEADS OF THE VERSE FENESTRATED SCREWS HAD TO BE RELEASED, THEREFORE THE FOUR SCREWS WERE REPLACED WITH SIZED-UP ONES, AND THE CONNECTION USING RODS WAS DONE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THIS REPORT INVOLVES ONE EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 7.0 X 45MM. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17304923 ↗
• MalfunctionJul 12, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT DURING A PLANNED SECOND SPINAL SURGERY (T12-L3) ON (B)(6) 2023, WHEN ATTEMPTING TO CONNECT T12-L3, THE LOCKS OF THE HEADS OF THE VERSE FENESTRATED SCREWS WERE NOT RELEASED, AND THE CONNECTION USING RODS COULD NOT BE APPLIED. THE FENESTRATED SCREWS HAD BEEN IMPLANTED IN THE FIRST SURGERY ON (B)(6) 2023. THERE WERE FOUR PLACES WHERE THE LOCKS OF THE HEADS OF THE VERSE FENESTRATED SCREWS HAD TO BE RELEASED, THEREFORE THE FOUR SCREWS WERE REPLACED WITH SIZED-UP ONES, AND THE CONNECTION USING RODS WAS DONE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THIS REPORT INVOLVES ONE EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 7.0 X 45MM. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17304919 ↗
• MalfunctionJul 12, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT DURING A PLANNED SECOND SPINAL SURGERY (T12-L3) ON (B)(6) 2023, WHEN ATTEMPTING TO CONNECT T12-L3, THE LOCKS OF THE HEADS OF THE VERSE FENESTRATED SCREWS WERE NOT RELEASED, AND THE CONNECTION USING RODS COULD NOT BE APPLIED. THE FENESTRATED SCREWS HAD BEEN IMPLANTED IN THE FIRST SURGERY ON (B)(6) 2023. THERE WERE FOUR PLACES WHERE THE LOCKS OF THE HEADS OF THE VERSE FENESTRATED SCREWS HAD TO BE RELEASED, THEREFORE THE FOUR SCREWS WERE REPLACED WITH SIZED-UP ONES, AND THE CONNECTION USING RODS WAS DONE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THIS REPORT INVOLVES ONE EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 7.0 X 45MM. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17304918 ↗
• MalfunctionFeb 14, 2023Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS:IT WAS REPORTED THAT DURING A POSTERIOR SPINAL FUSION PROCEDURE ON (B)(6) 2023, THE SURGEON WAS UNABLE TO PROPERLY ATTACH THE SCREW TO THE SCREWDRIVER. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THERE WAS NO ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE.THIS REPORT IS FOR AN EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 7.0 X 45MM.THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16371686 ↗
• InjuryFeb 8, 2023Device Slipped; Device Slipped

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A SPINAL FUSION (T10 TO L1) FOR THE VERTEBRAL BODY FRACTURE ON (B)(6) 2022. THE CEMENT WAS INJECTED INTO T10 AND L1 THROUGH THE SCREW. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. A FEW WEEKS AFTER SURGERY, THE L1 SCREW AND THE CEMENT HAD SEPARATED. THE SCREW WAS LOOSENED INSIDE OF THE VERTEBRAL BODY. ON (B)(6) 2023, THE REVISION SURGERY (T10 TO L3) WAS PERFORMED. ACCORDING TO THE SURGEON, THE SCREW AND THE CEMENT WERE SEPARATED, AND THE PATIENT WAS INFECTED. THE SURGEON GUESSED THAT LOSS OF VERTEBRAL FUSION OCCURRED DUE TO INFECTION, AND IT MAY CAUSE LOOSENING. CRP IS HIGH; HOWEVER, IT IS UNKNOWN IF INFECTION IS THE CAUSE. *REMARKS: (B)(4) AND (B)(4) ARE INVOLVED WITH THE SAME EVENT. (B)(4) (DEPUY SPINE): SCREW. (B)(4) (SYNTHES SPINE): CEMENT. THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE FEN SCR 7.0X45. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 16327263 ↗
• InjuryFeb 8, 2023Device Slipped; Device Slipped

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A SPINAL FUSION (T10 TO L1) FOR THE VERTEBRAL BODY FRACTURE ON (B)(6) 2022. THE CEMENT WAS INJECTED INTO T10 AND L1 THROUGH THE SCREW. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. A FEW WEEKS AFTER SURGERY, THE L1 SCREW AND THE CEMENT HAD SEPARATED. THE SCREW WAS LOOSENED INSIDE OF THE VERTEBRAL BODY. ON (B)(6) 2023, THE REVISION SURGERY (T10 TO L3) WAS PERFORMED. ACCORDING TO THE SURGEON, THE SCREW AND THE CEMENT WERE SEPARATED, AND THE PATIENT WAS INFECTED. THE SURGEON GUESSED THAT LOSS OF VERTEBRAL FUSION OCCURRED DUE TO INFECTION, AND IT MAY CAUSE LOOSENING. CRP IS HIGH; HOWEVER, IT IS UNKNOWN IF INFECTION IS THE CAUSE. REMARKS: (B)(4) ARE INVOLVED WITH THE SAME EVENT. (B)(4) (DEPUY SPINE): SCREW; (B)(4) (SYNTHES SPINE): CEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE FEN SCR 7.0X45. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4)

  Patient problems: Unspecified Infection

  MAUDE report 16327260 ↗
• InjuryJan 20, 2023Device Slipped; Device Slipped

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A POSTERIOR FUSION PERFORMED ON (B)(6) 2022. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. INITIALLY, THE PATIENT WAS DIAGNOSED WITH A COMPRESSION FRACTURE; HOWEVER, A FEW MONTHS AFTER THE SURGERY, TUBERCULOSIS WAS DISCOVERED. THE SCREW LOOSENED DUE TO TUBERCULOSIS. THE VERTEBRAL BODY WHERE THE VBS WAS PERFORMED WAS ALSO RE-FRACTURED. THEREFORE, THE REVISION SURGERY WAS PERFORMED. THIS REPORT IS FOR AN EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 7.0 X 45MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Bone Fracture(s); Inadequate Osseointegration; Unspecified Infection

  MAUDE report 16218097 ↗
• InjuryJan 20, 2023Device Slipped; Device Slipped

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A POSTERIOR FUSION PERFORMED ON (B)(6) 2022. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. INITIALLY, THE PATIENT WAS DIAGNOSED WITH A COMPRESSION FRACTURE; HOWEVER, A FEW MONTHS AFTER THE SURGERY, TUBERCULOSIS WAS DISCOVERED. THE SCREW LOOSENED DUE TO TUBERCULOSIS. THE VERTEBRAL BODY WHERE THE VBS WAS PERFORMED WAS ALSO RE-FRACTURED. THEREFORE, THE REVISION SURGERY WAS PERFORMED. THIS REPORT IS FOR AN EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 7.0 X 45MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Bone Fracture(s); Inadequate Osseointegration; Unspecified Infection

  MAUDE report 16218073 ↗
• 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: THE SCREW IN QUESTION WAS INSERTED INTO T10 AS PER SURGICAL TECHNIQUE. THE HA STICKS WERE INSERTED INTO T11 TO L2 AS PER SURGICAL TECHNIQUE. THE SCREW IN QUESTION WAS INSERTED INTO L5, AND THE CEMENT WAS MIXED. THE SCREW IN QUESTION WAS INSERTED INTO L4 WHILE MIXING THE CEMENT. THE CEMENT WAS INSERTED INTO THE SCREW IN QUESTION BEFORE THE SCREW WAS INSERTED INTO L3. 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 WAS COMPLETED SUCCES

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

  MAUDE report 15478148 ↗
• InjuryFeb 8, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A PATIENT WHO WAS EIGHT (8) MONTHS POST-OPS CAME TO THE OFFICE IN (B)(6) 2020. X-RAYS REVEALED S1 PEDICLE SCREW ON RIGHT WAS BROKEN. THE PATIENT EXPERIENCED UNSPECIFIED ADVERSE EVENT. A REVISION SURGERY HAPPENED ON (B)(6) 2021 DUE TO NON-UNION/BROKEN SCREW. THE PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. CONCOMITANT DEVICE REPORTED: 5.5 EXP VERSE FEN SCR 7.0X45 (PART# 199723745S, LOT# UNKNOWN, QUANTITY 2). 5.5 EXP VERSE FEN SCR 7.0X50 (PART# 199723750S, LOT# UNKNOWN, QUANTITY 2). 5.5 EXP VERSE UNITIZED SET SCR (PART# 199721001 , LOT# UNKNOWN, QUANTITY 4). VIPER2 LORDOTIC ROD-35MM (PART# 186788035, LOT# UNKNOWN, QUANTITY 1). VIPER2 LORDOTIC ROD-40MM (PART#186788040, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) 5.5 EXP VERSE FEN SCR 7.0X45. THIS IS REPORT 1 OF 1 (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11297810 ↗
• InjurySep 24, 2018Break; Break

  THE FOLLOWING WAS REPORTED: SPINAL FIXATION OR SPONDY GRADE 1 L4-5. SIX (6) MONTHS AFTER SURGERY THE TREATING PHYSICIAN NOTICED THAT ONE SCREW (L5) WAS BROKEN. ALL LOCKING CAPS (UNITIZED) WERE TIGHTENED ACCORDING TO THE SURGICAL TECHNIQUE AND DOUBLE CHECKED DURING SURGERY FOR CORRECT LOCKING TORQUE. THE SCREW 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 1 AT LEVEL L4-5. PRIMARY SURGERY DATE (B)(6) 2018. PATIENT GENDER UNKNOWN. DOB UNKNOWN. NO OTHER PATIENT DATA IS AVAILABLE. WHEN DID THE DEVICE PROBLEM OCCUR? WITHIN 6 MONTHS AFTER PRIMARY IMPLANTATION.

  Patient problems: Not Applicable

  MAUDE report 7902015 ↗
• 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 7756611 ↗
• 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 7756453 ↗
• InjuryAug 7, 2018Break; Break

  SPINAL FIXATION OR SPONDY GRADE 2 L4-5 6 MONTHS AFTER SURGERY THE TREATING PHYSICIAN NOTICED THAT ONE SCREW WAS BROKEN. ALL LOCKING CAPS WERE TIGHTENED ACCORDING TO THE SURGICAL TECHNIQUE AND DOUBLE CHECKED DURING SURGERY FOR CORRECT TORQUE LOCKING. THE SCREW 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 L4-5. PRIMARY SURGERY DATE (B)(6) 2017. NO OTHER PATIENT DATA IS AVAILABLE.

  Patient problems: Spinal Column Injury

  MAUDE report 7756355 ↗