EXPEDIUM VERSE 199723645SRecalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10705034443515), received between Dec 18, 2018 and Jul 27, 2026 — classified as 2 deaths, 22 injuries, 5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 27, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50018299 ↗
• InjuryNov 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT THE REOPERATION ON (B)(6) 2023 WITH L3-S SCREW REMOVAL, L2/3 TLIF (NON JJ PRODUCT: TRITANIUM), L2-SAI SCREW INSERTION (JJ PRODUCTS: VERSEFS, EXPEDIUM DI, AND EXPEDIUM SAI). ON (B)(6) 2025, A L1/2 TLIF WAS PERFORMED DUE TO ADJACENT SEGMENT DYSFUNCTION. L2 TO SAI WERE LEFT AS IS. VERSEFS (1.8CC CEMENT EACH) WAS USED FOR L1, AND RISE (GLOBUS) WAS USED FOR L1/2. CRANK RODS (NUVASIVE) AND ROD CONNECTORS WERE USED TO CONNECT TO THE EXISTING RODS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. AFTER THE SURGERY, THE SALES REP RECEIVED A COMPLAINT AFTER A CT SCAN ON (B)(6) 2025, SHOWED BILATERAL BREAKAGE OF THE L1 SCREW IN A PATIENT WHO UNDERWENT L1/2 TLIF (VERSEFS + RISE (GLOBUS)). THE SCREW BROKE NEAR THE LATERAL HOLE OF THE SCREW. IT IS CURRENTLY UNDECIDED WHETHER OR NOT TO PERFORM SURGERY ON THIS PATIENT IN THE FUTURE. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT AND(B)(4) REPORTS THE REVISION SURGERY PERFORMED ON (B)(6) 2025 WHILE RELATED (B)(4) REPORTS THE BREAKAGE OF THE SCREW OCCURRED AFTER THE SURGERY PERFORMED ON (B)(6) 2025.

  Patient problems: Osteolysis

  MAUDE report 23490966 ↗
• InjuryNov 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT THE REOPERATION ON (B)(6) 2023 WITH L3-S SCREW REMOVAL, L2/3 TLIF (NON-JJ PRODUCT: TRITANIUM), L2-SAI SCREW INSERTION (JJ PRODUCTS: VERSEFS, EXPEDIUM DI, AND EXPEDIUM SAI). ON (B)(6) 2025, A L1/2 TLIF WAS PERFORMED DUE TO ADJACENT SEGMENT DYSFUNCTION. L2 TO SAI WERE LEFT AS IS. VERSEFS (1.8CC CEMENT EACH) WAS USED FOR L1, AND RISE (GLOBUS) WAS USED FOR L1/2. CRANK RODS (NUVASIVE) AND ROD CONNECTORS WERE USED TO CONNECT TO THE EXISTING RODS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. AFTER THE SURGERY, THE SALES REP RECEIVED A COMPLAINT AFTER A CT SCAN ON (B)(6) 2025, SHOWED BILATERAL BREAKAGE OF THE L1 SCREW IN A PATIENT WHO UNDERWENT L1/2 TLIF (VERSEFS + RISE (GLOBUS). THE SCREW BROKE NEAR THE LATERAL HOLE OF THE SCREW. IT IS CURRENTLY UNDECIDED WHETHER OR NOT TO PERFORM SURGERY ON THIS PATIENT IN THE FUTURE. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT AND (B)(4) REPORTS THE REVISION SURGERY PERFORMED ON (B)(6) 2025 WHILE RELATED (B)(4) REPORTS THE BREAKAGE OF THE SCREW OCCURRED AFTER THE SURGERY PERFORMED ON (B)(6) 2025.

  Patient problems: Osteolysis

  MAUDE report 23490957 ↗
• InjuryOct 31, 2025Break; Break

  IT WAS REPORTED THE PATIENT UNDERWENT AN L1/2 TLIF ON (B)(6) 2025; THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. ON (B)(6) 2025 A CT SCAN SHOWED BILATERAL BREAKAGE OF THE L1 SCREW; THE SCREW BROKE NEAR THE LATERAL HOLE OF THE SCREW.

  Patient problems: Osteolysis

  MAUDE report 23439153 ↗
• InjuryOct 31, 2025Break; Break

  IT WAS REPORTED THE PATIENT UNDERWENT AN L1/2 TLIF ON (B)(6) 2025; THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. ON (B)(6) 2025, A CT SCAN SHOWED BILATERAL BREAKAGE OF THE L1 SCREW; THE SCREW BROKE NEAR THE LATERAL HOLE OF THE SCREW.

  Patient problems: Osteolysis

  MAUDE report 23439133 ↗
• MalfunctionAug 21, 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 FEN SCR 6.0X45. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 20014482 ↗
• MalfunctionNov 16, 2023Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A POSTERIOR LUMBAR FUSION (L3) FOR VERTEBRAL COMPRESSION FRACTURE ON OCT. 30, 2023. REGARDING THE VERTEBRAL COMPRESSION FRACTURE ON L1, VERTEBRAL BODY STENTING WAS USED FOR L1 AND VERSE FS OR PRIME WAS USED FOR TH11-L3 IN THE SURGERY, THE SURGEON USED THE SCREW IN QUESTION ON L3, AND ATTEMPTED THE CEMENT INJECTION. THE FS ALIGNMENT DEVICE AND MODIFIED ALIGNMENT DEVICE ADAPTER WERE STUCK. THE SURGEON HELD THE ALIGNMENT DEVICE AND PULLED THE HANDLE UPWARD, BUT IT DID NOT COME OFF. WHEN HE PULLED UP WITH MORE FORCE, THE SCREW IN QUESTION BACKED OUT. THE ALIGNMENT DEVICE AND MODIFIED ADAPTER WERE CHANGED TO ANOTHER ONE, AND A F7.0 × 45 MM SCREW WAS INSERTED. THE ALIGNMENT DEVICE AND THE MODIFIED ADAPTER WERE REMOVED BY TAPPING THEM WITH A HAMMER. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 30 MINUTES ANY SURGICAL DELAY. PATIENT STATUS/ OUTCOME: STABLE NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE FEN SCR 6.0X45 THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18150870 ↗
• InjuryOct 18, 2023Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND FOLLOWS: IT WAS REPORTED ON SEPTEMBER 30, 2023, OF REVISION: SCREW BELOW THE HEAD BROKEN (VERSE ADVANCED). THE SCREW SHAFT WAS STILL IN THE VERTEBRAL BODY (PREVIOUS SURGERY), AND THE SURGEON TRIED TO REMOVE IT WITH THE REMOVAL KIT (OPERACE). THERE WAS A SURGICAL DELAY DUE TO THE REPORTED EVENT. THE SURGERY WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE FEN SCR 6.0X45. THIS IS REPORT 1 OF 1 FOR COMPLAINT: (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 17957620 ↗
• InjuryFeb 23, 2023Device Slipped; Device Slipped

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR FUSION ON (B)(6) 2022. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. ON (B)(6) 2022, A REVISION SURGERY WAS PERFORMED FOR AN UNKNOWN REASON. MESH CAGE WAS INSTALLED IN VCR AREA. IN (B)(6), THE MESH CAGE FELL INTO THE LOWER VERTEBRAL BODY AND BECAME UNSTABLE. THE IMAGE SHOWED THAT THE SCREWS WERE LOOSENED. THEREFORE, A SECOND REVISION SURGERY WAS PERFORMED. THE SPECIFIC DATE OF THE EVENT IS UNKNOWN, AS IT DEVELOPED GRADUALLY. THIS REPORT INVOLVES ONE EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 6.0 X 45MM. THIS REPORT IS RELATED TO (B)(4), WHICH REPORTS THE MESH CAGE. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 16432274 ↗
• InjuryFeb 23, 2023Device Slipped; Device Slipped

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR FUSION ON (B)(6) 2022. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. ON (B)(6) 2022, A REVISION SURGERY WAS PERFORMED FOR AN UNKNOWN REASON. MESH CAGE WAS INSTALLED IN VCR AREA. IN (B)(6), THE MESH CAGE FELL INTO THE LOWER VERTEBRAL BODY AND BECAME UNSTABLE. THE IMAGE SHOWED THAT THE SCREWS WERE LOOSENED. THEREFORE, A SECOND REVISION SURGERY WAS PERFORMED. THE SPECIFIC DATE OF THE EVENT IS UNKNOWN, AS IT DEVELOPED GRADUALLY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 6.0 X 45MM. THIS REPORT IS RELATED TO (B)(4) WHICH REPORTS THE MESH CAGE. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 16432052 ↗
• DeathJan 6, 2023Adverse 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 (B)(6) 2022, AN UNKNOWN SURGERY WAS PERFORMED WITH THE SCREW IN QUESTION. AFTER INSERTION OF THE SCREWS, THE PATIENT¿S CONDITION SUDDENLY CHANGED. THE OPERATION WAS CANCELLED IN THE MIDDLE OF THE PROCEDURE. AFTER THE SURGERY, IT WAS CONFIRMED BY CT THAT THERE WERE NO PROBLEMS WITH THE SCREW AND THE IMPLANTS. NO OTHER MEDICAL INTERVENTION WAS REQUIRED. THERE WAS NO DELAY IN SURGERY. THE PATIENT WENT INTO CARDIAC ARREST AND LATER DIED OF HEART FAILURE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 6.0 X 45MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Cardiac Arrest

  MAUDE report 16111424 ↗
• DeathJan 6, 2023Adverse 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 (B)(6) 2022, AN UNKNOWN SURGERY WAS PERFORMED WITH THE SCREW IN QUESTION. AFTER INSERTION OF THE SCREWS, THE PATIENT¿S CONDITION SUDDENLY CHANGED. THE OPERATION WAS CANCELLED IN THE MIDDLE OF THE PROCEDURE. AFTER THE SURGERY, IT WAS CONFIRMED BY CT THAT THERE WERE NO PROBLEMS WITH THE SCREW AND THE IMPLANTS. NO OTHER MEDICAL INTERVENTION WAS REQUIRED. THERE WAS NO DELAY IN SURGERY. THE PATIENT WENT INTO CARDIAC ARREST AND LATER DIED OF HEART FAILURE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 6.0 X 45MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Cardiac Arrest

  MAUDE report 16111418 ↗
• InjuryDec 12, 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 AN UNKNOWN SURGERY PERFORMED ON UNKNOWN DATE. AFTER THE SURGERY, BACK-OUT OF THE SCREW OCCURRED DUE TO SPONDYLITIS. ON (B)(6) 2022, A REVISION SURGERY WILL BE PERFORMED. CAUSE OF INFECTION IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE FEN SCR 6.0X45. THIS IS REPORT 2 OF 2 FOR COMPLAINT: (B)(4).

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 15960145 ↗
• InjuryDec 12, 2022Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS AN UNKNOWN SURGERY PERFORMED ON UNKNOWN DATE. AFTER THE SURGERY, BACK-OUT OF THE SCREW OCCURRED DUE TO SPONDYLITIS. ON (B)(6) 2022, A REVISION SURGERY WILL BE PERFORMED. CAUSE OF INFECTION IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE FEN SCR 6.0X45. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 15960134 ↗
• 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 15479582 ↗
• 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 15478743 ↗
• InjuryDec 20, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE POSTERIOR SPINAL FUSION (T12: FRACTURE, 1A1B, INTERVERTEBRAL FUSION: T11~L1) FOR THE OSTEOPOROTIC COMPRESSION FRACTURE. THE CEMENT WAS INJECTED TO REINFORCE THE SCREWS. THE AMOUNT OF CEMENT WAS 1.5 ML AT T11 AND 3.0 ML AT L1. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. ON (B)(6) 2021, KYPHOSIS OF THE SPINE AND VERTEBRAL BODY FRACTURE WERE CONFIRMED DURING CONSULTATION. THE PATIENT HAS PARKINSON'S DISEASE. HE ALSO REPORTED THAT HE HAD FALLEN ON HIS BEHIND. THE SURGEON COMMENTED IN HIS OPINION, THE SCREW WOULD HAVE BEEN LOOSENED NORMALLY WHEN IT WAS SUBJECTED TO KYPHOTIC FORCE DUE TO PARKINSON'S DISEASE, BUT THIS TIME, IT WAS REINFORCED WITH CEMENT, SO STRESS CONCENTRATED ON THE VERTEBRAL BODY AND IT BROKE. THE LIKELY CAUSE OF THIS WAS THE PATIENT'S BONE QUALITY AND SHORT FUSION RANGE, AS WELL AS CEMENT INJECTION VOLUME (DIFFERENCE IN CEMENT INJECTION VOLUME BETWEEN THE APICAL AND CAUDAL VERTEBRAL BODIES) AND EXTERNAL STRESS (FALL). AT PRESENT, NO SYMPTOMS HAVE DEVELOPED, BUT IF LEFT UNTREATED, NEUROLOGICAL SYMPTOMS MAY DEVELOP. THERE

  Patient problems: Failure of Implant

  MAUDE report 13046842 ↗
• InjuryApr 9, 2021Break; Break

  CONCOMITANT DEVICE REPORTED: MMSI ROD PREBENT, 5.5 X55MM, T(PART# 179772055S , LOT# UNKNOWN, QUANTITY UNKNOWN ). 5.5 EXP VERSE FEN SCR 6.0X45 T(PART# 199723645S, LOT# UNKNOWN, QUANTITY UNKNOWN ). THIS COMPLAINT INVOLVES EIGHT (8) DEVICES.

  Patient problems: Pain

  MAUDE report 11641703 ↗
• InjuryApr 9, 2021Break; Break

  ADDITIONAL EVENT INFORMATION. CONCOMITANT DEVICE REPORTED: MMSI ROD PREBENT, 5.5 X55MM, T(PART# 179772055S , LOT# UNKNOWN, QUANTITY UNKNOWN ). 5.5 EXP VERSE FEN SCR 6.0X45 T(PART# 199723645S, LOT# UNKNOWN, QUANTITY UNKNOWN ). THIS COMPLAINT INVOLVES EIGHT (8) DEVICES.

  Patient problems: Pain

  MAUDE report 11641679 ↗
• InjuryApr 9, 2021Break; Break

  ADDITIONAL EVENT INFORMATION. CONCOMITANT DEVICE REPORTED: MMSI ROD PREBENT, 5.5 X55MM, T(PART# 179772055S , LOT# UNKNOWN, QUANTITY UNKNOWN ). 5.5 EXP VERSE FEN SCR 6.0X45 T(PART# 199723645S, LOT# UNKNOWN, QUANTITY UNKNOWN ) . THIS COMPLAINT INVOLVES EIGHT (8) DEVICES.

  Patient problems: Pain

  MAUDE report 11641667 ↗
• InjuryApr 9, 2021Break; Break

  ADDITIONAL EVENT INFORMATION CONCOMITANT DEVICE REPORTED: MMSI ROD PREBENT, 5.5 X55MM, T(PART# 179772055S , LOT# UNKNOWN, QUANTITY UNKNOWN). 5.5 EXP VERSE FEN SCR 6.0X45 T(PART# 199723645S, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES EIGHT (8) DEVICES.

  Patient problems: Pain

  MAUDE report 11641645 ↗
• MalfunctionFeb 19, 2021Migration; Migration

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 A POSTERIOR SPINAL FUSION WAS PERFORMED TO TREAT A 12TH THORACIC BURST FRACTURE. ON AN UNKNOWN DATE, THE CT REVEALED THAT THE SCREWS HAD DEVIATED TO THE SPINAL CANAL, WHICH CAUSED THE CEMENT TO LEAK INTO THE INSIDE OF THE SPINAL CANAL. ADDITIONAL INFORMATION: THE PATIENT WAS NOT ABLE TO RAISE HER UPPER TORSO BEFORE THE PROCEDURE BUT CAN RAISE THE TORSO POSTOPERATIVELY. NO ADVERSE EFFECT TO THE PATIENT HAS BEEN REPORTED. THERE IS NO PLAN FOR AN ADDITIONAL MEDICAL INTERVENTION BUT KEEP MEDICAL FOLLOW-UPS. THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE FEN SCR 6.0X45. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11350081 ↗
• MalfunctionFeb 19, 2021Migration; Migration

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 A POSTERIOR SPINAL FUSION WAS PERFORMED TO TREAT A 12TH THORACIC BURST FRACTURE. ON AN UNKNOWN DATE, THE CT REVEALED THAT THE SCREWS HAD DEVIATED TO THE SPINAL CANAL, WHICH CAUSED THE CEMENT TO LEAK INTO THE INSIDE OF THE SPINAL CANAL. ADDITIONAL INFORMATION: THE PATIENT WAS NOT ABLE TO RAISE HER UPPER TORSO BEFORE THE PROCEDURE BUT CAN RAISE THE TORSO POSTOPERATIVELY. NO ADVERSE EFFECT TO THE PATIENT HAS BEEN REPORTED. THERE IS NO PLAN FOR AN ADDITIONAL MEDICAL INTERVENTION BUT KEEP MEDICAL FOLLOW-UPS. THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE FEN SCR 6.0X45. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11349976 ↗
• InjuryJan 11, 2021Migration; Migration

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE VERSE SCREWS BECAME DISLODGED DUE TO THE PATIENT FALLING ON (B)(6) 2020. THERE WAS A FRACTURE AT THE T10 VERTEBRAE REPORTED. REVISION SURGERY WAS COMPLETED ON (B)(6) 2020. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS UNKNOWN. THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE FEN SCR 6.0X45. THIS IS REPORT 2 OF 2 FOR (B)(4).

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

  MAUDE report 11147875 ↗
• InjuryJan 11, 2021Migration; Migration

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE VERSE SCREWS BECAME DISLODGED DUE TO THE PATIENT FALLING ON (B)(6) 2020. THERE WAS A FRACTURE AT THE T10 VERTEBRAE REPORTED. REVISION SURGERY WAS COMPLETED ON (B)(6) 2020. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS UNKNOWN. THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE FEN SCR 6.0X45. THIS IS REPORT 1 OF 2 FOR (B)(4).

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

  MAUDE report 11147862 ↗