EXPEDIUM VERSE 199721640Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 10705034442280), received between Mar 11, 2019 and Sep 16, 2024 — classified as 30 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2024Material Twisted/Bent; Material Twisted/Bent

  ADDITIONAL INFORMATION RECEIVED STATES THAT NO FURTHER SURGICAL INTERVENTION WAS NECESSARY. THERE WERE NO FRAGMENTS OF ANY TYPE OF DAMAGED INSTRUMENTS IN THE PATIENT. DAMAGE IS UNDERSTOOD TO BE THE DEFICIENCY IN THE OPERATION OF THE EQUIPMENT LISTED IN THE REPORT; THE MALFUNCTION OF THESE PARTS AFFECTED OTHER REFERENCES SUCH AS THE LOCKING SCREWS AND TRANSPEDICULAR SCREWS.

  Patient problems: Insufficient Information

  MAUDE report 20224457 ↗
• MalfunctionAug 22, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A RESTOCK ORDER WAS PLACED FOR EXPEDIUM VERSE, AND THE TABS WERE BROKEN OFF OF TWO OF THE SCREWS AND REPACKAGED. THERE WAS NO PATIENT INVOLVEMENT. SALES REP ALSO SENT A 4 LEVEL VECTRA PLATE IN THE SAME BOX. THIS REPORT INVOLVES ONE EXPEDIUM VERSE SPINE SYSTEM POLYAXIAL SCREW 5.5 6.0 X 40MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20032328 ↗
• 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 40. THIS REPORT IS 1 OF 7 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10945390 ↗
• 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 45 (PART NUMBER 199721645, LOT 240964, 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 40MM. THIS IS REPORT 7 OF 8 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10540306 ↗
• 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 45 (PART NUMBER 199721645, LOT 240964, QUANTITY 1), 5.5 EXP VERSE SCREW 6.0 X 40 (PART NUMBER 199721640, LOT 226103, 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 40MM. THIS IS REPORT 8 OF 8 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10540302 ↗
• 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 40. THIS IS REPORT 2 OF 7 (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 10535688 ↗
• InjurySep 15, 2020Unintended Movement; Unintended Movement

  DEVICE REPORT FROM PORTUGAL 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)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 10535676 ↗
• InjuryJun 5, 2020Break; Break

  UPDATED EVENT DESCRIPTION: THE METALS WERE THE INNER THREADS OF THE SCREW GENERATED WHEN THE SURGEON TRIED TO INSERT AND REMOVE THE LOCK SEVERAL TIMES AND CHANGED LOCKS.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 10126142 ↗
• InjuryJun 5, 2020Break; Break

  UPDATED EVENT DESCRIPTION: THE METALS WERE THE INNER THREADS OF THE SCREW GENERATED WHEN THE SURGEON TRIED TO INSERT AND REMOVE THE LOCK SEVERAL TIMES AND CHANGED LOCKS.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 10126140 ↗
• InjuryJun 5, 2020Break; Break

  UPDATED EVENT DESCRIPTION: THE METALS WERE THE INNER THREADS OF THE SCREW GENERATED WHEN THE SURGEON TRIED TO INSERT AND REMOVE THE LOCK SEVERAL TIMES AND CHANGED LOCKS.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 10126137 ↗
• InjuryJun 5, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A FRACTURE FIXATION SURGERY WITH EXPEDIUM VERSE SYSTEM AT RAMBAM MEDICAL CENTER, THE SCREW ALONG WITH 3 DIFFERENT INNERS WERE ERODED AND SHED METAL PIECES IN THE PATIENT BODY. THERE WERE NO MEDICAL EFFECTS ON THE PATIENT AND NO LONGER HOSPITALIZATION REQUIRED FOLLOWING THE INCIDENT. THE PRODUCT PARTICLES WERE COLLECTED FROM THE PATIENT'S BODY, AND ACCORDING TO THE EVALUATION OF THE REPRESENTATIVE WHO PARTICIPATED IN THE ANALYSIS, NO FRAGMENTS / DEBRIS REMAINED IN THE PATIENT'S BODY THERE WAS A SURGERY DELAYED DUE TO THE REPORTED EVENT OF 60 MINUTES. THIS COMPLAINT INVOLVES NINE (9) DEVICES. THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE SCREW 6.0 X 40. THIS REPORT IS 7 OF 9 FOR (B)(4).

  Patient problems: No Code Available; Not Applicable

  MAUDE report 10126134 ↗
• InjuryMay 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON AN UNKNOWN DATE, ON (B)(6) 2015, THE PATIENT PRESENTED WITH THE COMPLAINTS OF SHOULDER PAIN WHICH REVEALED SCOLIOSIS OBTAINED ON RADIOLOGICAL STUDIES. HOWEVER, THEY FAILED TO DIAGNOSE SCOLIOSIS OR HAVE THE PATIENT SCOLIOSIS EVALUATION. ON (B)(6) 2018, THE PATIENT CAME WITH THE COMPLAINTS OF UPPER BACK PAIN PRIMARILY IN THE LEFT-MID-THORACIC SPINE RADIATING TO THE LEFT AND RIGHT BUTTOCKS. THE PAIN WAS INTERMITTENT, MODERATE ACHE WITH NO HISTORY OF BACK PAIN BEFORE. ON (B)(6) 2018, THE PATIENT EXPLAINED THAT HE HAD LOW BACK PAIN AND OCCASIONAL THIGH PAIN. THE PATIENT DENIED OF RADIATING PAIN, NUMBNESS OR TINGLING IN HER EXTREMITIES. THE PATIENT WAS SCHEDULED THEN WITH POSTERIOR INSTRUMENTED FUSION T2 TO L4 VERTEBRAL BODIES. THE NEED FOR THE SURGERY WAS URGENT BECAUSE IT WAS NOT DETECTED EARLIER. ON (B)(6) 2018, THE SURGEON RECOMMENDED AND AGREED TO HAVE URGENT SURGERY TO THE PATIENT WITH MORE CONSERVATIVE TREATMENT. ON (B)(6) 2018, THEY BEGAN THE SURGERY (POSTERIOR INSTRUMENTED FUSION T2 TO L4. BUT WHEN THE PATIENT AWOKE FROM THE SURGERY, THE PATIENT WAS COMPLETELY PARALYZED FROM HER CHEST DOWN WITH THE MOTOR-SENSORY LOSS FROM T4 TO HER TOES. AND NOW SUFFERS FROM D

  Patient problems: Injury; Neurological Deficit/Dysfunction; Paralysis; Unspecified Nervous System Problem

  MAUDE report 10045038 ↗
• InjuryMay 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON AN UNKNOWN DATE, ON (B)(6) 2015, THE PATIENT PRESENTED WITH THE COMPLAINTS OF SHOULDER PAIN WHICH REVEALED SCOLIOSIS OBTAINED ON RADIOLOGICAL STUDIES. HOWEVER, THEY FAILED TO DIAGNOSE SCOLIOSIS OR HAVE THE PATIENT SCOLIOSIS EVALUATION. ON (B)(6) 2018, THE PATIENT CAME WITH THE COMPLAINTS OF UPPER BACK PAIN PRIMARILY IN THE LEFT-MID-THORACIC SPINE RADIATING TO THE LEFT AND RIGHT BUTTOCKS. THE PAIN WAS INTERMITTENT, MODERATE ACHE WITH NO HISTORY OF BACK PAIN BEFORE. ON (B)(6) 2018, THE PATIENT EXPLAINED THAT HE HAD LOW BACK PAIN AND OCCASIONAL THIGH PAIN. THE PATIENT DENIED OF RADIATING PAIN, NUMBNESS OR TINGLING IN HER EXTREMITIES. THE PATIENT WAS SCHEDULED THEN WITH POSTERIOR INSTRUMENTED FUSION T2 TO L4 VERTEBRAL BODIES. THE NEED FOR THE SURGERY WAS URGENT BECAUSE IT WAS NOT DETECTED EARLIER. ON (B)(6) 2018, THE SURGEON RECOMMENDED AND AGREED TO HAVE URGENT SURGERY TO THE PATIENT WITH MORE CONSERVATIVE TREATMENT. ON (B)(6) 2018, THEY BEGAN THE SURGERY (POSTERIOR INSTRUMENTED FUSION T2 TO L4. BUT WHEN THE PATIENT AWOKE FROM THE SURGERY, THE PATIENT WAS COMPLETELY PARALYZED FROM HER CHEST DOWN WITH THE MOTOR-SENSORY LOSS FROM T4 TO HER TOES. AND NOW SUFFERS FROM D

  Patient problems: Injury; Neurological Deficit/Dysfunction; Paralysis; Unspecified Nervous System Problem

  MAUDE report 10045035 ↗
• InjuryMay 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON AN UNKNOWN DATE, ON (B)(6) 2015, THE PATIENT PRESENTED WITH THE COMPLAINTS OF SHOULDER PAIN WHICH REVEALED SCOLIOSIS OBTAINED ON RADIOLOGICAL STUDIES. HOWEVER, THEY FAILED TO DIAGNOSE SCOLIOSIS OR HAVE THE PATIENT SCOLIOSIS EVALUATION. ON (B)(6) 2018, THE PATIENT CAME WITH THE COMPLAINTS OF UPPER BACK PAIN PRIMARILY IN THE LEFT-MID-THORACIC SPINE RADIATING TO THE LEFT AND RIGHT BUTTOCKS. THE PAIN WAS INTERMITTENT, MODERATE ACHE WITH NO HISTORY OF BACK PAIN BEFORE. ON (B)(6) 2018, THE PATIENT EXPLAINED THAT HE HAD LOW BACK PAIN AND OCCASIONAL THIGH PAIN. THE PATIENT DENIED OF RADIATING PAIN, NUMBNESS OR TINGLING IN HER EXTREMITIES. THE PATIENT WAS SCHEDULED THEN WITH POSTERIOR INSTRUMENTED FUSION T2 TO L4 VERTEBRAL BODIES. THE NEED FOR THE SURGERY WAS URGENT BECAUSE IT WAS NOT DETECTED EARLIER. ON (B)(6) 2018, THE SURGEON RECOMMENDED AND AGREED TO HAVE URGENT SURGERY TO THE PATIENT WITH MORE CONSERVATIVE TREATMENT. ON (B)(6) 2018, THEY BEGAN THE SURGERY (POSTERIOR INSTRUMENTED FUSION T2 TO L4. BUT WHEN THE PATIENT AWOKE FROM THE SURGERY, THE PATIENT WAS COMPLETELY PARALYZED FROM HER CHEST DOWN WITH THE MOTOR-SENSORY LOSS FROM T4 TO HER TOES. AND NOW SUFFERS FROM D

  Patient problems: Injury; Neurological Deficit/Dysfunction; Paralysis; Unspecified Nervous System Problem

  MAUDE report 10045031 ↗
• InjuryMay 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON AN UNKNOWN DATE, ON (B)(6) 2015, THE PATIENT PRESENTED WITH THE COMPLAINTS OF SHOULDER PAIN WHICH REVEALED SCOLIOSIS OBTAINED ON RADIOLOGICAL STUDIES. HOWEVER, THEY FAILED TO DIAGNOSE SCOLIOSIS OR HAVE THE PATIENT SCOLIOSIS EVALUATION. ON (B)(6) 2018, THE PATIENT CAME WITH THE COMPLAINTS OF UPPER BACK PAIN PRIMARILY IN THE LEFT-MID-THORACIC SPINE RADIATING TO THE LEFT AND RIGHT BUTTOCKS. THE PAIN WAS INTERMITTENT, MODERATE ACHE WITH NO HISTORY OF BACK PAIN BEFORE. ON (B)(6) 2018, THE PATIENT EXPLAINED THAT HE HAD LOW BACK PAIN AND OCCASIONAL THIGH PAIN. THE PATIENT DENIED OF RADIATING PAIN, NUMBNESS OR TINGLING IN HER EXTREMITIES. THE PATIENT WAS SCHEDULED THEN WITH POSTERIOR INSTRUMENTED FUSION T2 TO L4 VERTEBRAL BODIES. THE NEED FOR THE SURGERY WAS URGENT BECAUSE IT WAS NOT DETECTED EARLIER. ON (B)(6) 2018, THE SURGEON RECOMMENDED AND AGREED TO HAVE URGENT SURGERY TO THE PATIENT WITH MORE CONSERVATIVE TREATMENT. ON (B)(6) 2018, THEY BEGAN THE SURGERY (POSTERIOR INSTRUMENTED FUSION T2 TO L4. BUT WHEN THE PATIENT AWOKE FROM THE SURGERY, THE PATIENT WAS COMPLETELY PARALYZED FROM HER CHEST DOWN WITH THE MOTOR-SENSORY LOSS FROM T4 TO HER TOES. AND NOW SUFFERS FROM D

  Patient problems: Injury; Neurological Deficit/Dysfunction; Paralysis; Unspecified Nervous System Problem

  MAUDE report 10045030 ↗
• InjuryMay 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON AN UNKNOWN DATE, ON (B)(6) 2015, THE PATIENT PRESENTED WITH THE COMPLAINTS OF SHOULDER PAIN WHICH REVEALED SCOLIOSIS OBTAINED ON RADIOLOGICAL STUDIES. HOWEVER, THEY FAILED TO DIAGNOSE SCOLIOSIS OR HAVE THE PATIENT SCOLIOSIS EVALUATION. ON (B)(6) 2018, THE PATIENT CAME WITH THE COMPLAINTS OF UPPER BACK PAIN PRIMARILY IN THE LEFT-MID-THORACIC SPINE RADIATING TO THE LEFT AND RIGHT BUTTOCKS. THE PAIN WAS INTERMITTENT, MODERATE ACHE WITH NO HISTORY OF BACK PAIN BEFORE. ON (B)(6) 2018, THE PATIENT EXPLAINED THAT HE HAD LOW BACK PAIN AND OCCASIONAL THIGH PAIN. THE PATIENT DENIED OF RADIATING PAIN, NUMBNESS OR TINGLING IN HER EXTREMITIES. THE PATIENT WAS SCHEDULED THEN WITH POSTERIOR INSTRUMENTED FUSION T2 TO L4 VERTEBRAL BODIES. THE NEED FOR THE SURGERY WAS URGENT BECAUSE IT WAS NOT DETECTED EARLIER. ON (B)(6) 2018, THE SURGEON RECOMMENDED AND AGREED TO HAVE URGENT SURGERY TO THE PATIENT WITH MORE CONSERVATIVE TREATMENT. ON (B)(6) 2018, THEY BEGAN THE SURGERY (POSTERIOR INSTRUMENTED FUSION T2 TO L4. BUT WHEN THE PATIENT AWOKE FROM THE SURGERY, THE PATIENT WAS COMPLETELY PARALYZED FROM HER CHEST DOWN WITH THE MOTOR-SENSORY LOSS FROM T4 TO HER TOES. AND NOW SUFFERS FROM D

  Patient problems: Injury; Neurological Deficit/Dysfunction; Paralysis; Unspecified Nervous System Problem

  MAUDE report 10045027 ↗
• InjuryMay 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONALLY IT WAS REPORTED THAT ON JUNE 26, 2018 PATIENT A SUBSEQUENT REMOVAL OF SPINAL HARDWARE INCLUDING BILATERAL RODS, T2 HOOKS BILATERALLY, RIGHT T5 SCREW AND LEFT T9 AND T10. THIS INTERVENTION WAS NOTED FOR PARTIAL CORRECTION OF PATIENT'S DEFORMITY.

  Patient problems: Injury; Neurological Deficit/Dysfunction; Paralysis; Unspecified Nervous System Problem

  MAUDE report 10045026 ↗
• InjuryMay 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON AN UNKNOWN DATE, ON (B)(6) 2015, THE PATIENT PRESENTED WITH THE COMPLAINTS OF SHOULDER PAIN WHICH REVEALED SCOLIOSIS OBTAINED ON RADIOLOGICAL STUDIES. HOWEVER, THEY FAILED TO DIAGNOSE SCOLIOSIS OR HAVE THE PATIENT SCOLIOSIS EVALUATION. ON (B)(6) 2018, THE PATIENT CAME WITH THE COMPLAINTS OF UPPER BACK PAIN PRIMARILY IN THE LEFT-MID-THORACIC SPINE RADIATING TO THE LEFT AND RIGHT BUTTOCKS. THE PAIN WAS INTERMITTENT, MODERATE ACHE WITH NO HISTORY OF BACK PAIN BEFORE. ON (B)(6) 2018, THE PATIENT EXPLAINED THAT HE HAD LOW BACK PAIN AND OCCASIONAL THIGH PAIN. THE PATIENT DENIED OF RADIATING PAIN, NUMBNESS OR TINGLING IN HER EXTREMITIES. THE PATIENT WAS SCHEDULED THEN WITH POSTERIOR INSTRUMENTED FUSION T2 TO L4 VERTEBRAL BODIES. THE NEED FOR THE SURGERY WAS URGENT BECAUSE IT WAS NOT DETECTED EARLIER. ON (B)(6) 2018, THE SURGEON RECOMMENDED AND AGREED TO HAVE URGENT SURGERY TO THE PATIENT WITH MORE CONSERVATIVE TREATMENT. ON (B)(6) 2018, THEY BEGAN THE SURGERY (POSTERIOR INSTRUMENTED FUSION T2 TO L4. BUT WHEN THE PATIENT AWOKE FROM THE SURGERY, THE PATIENT WAS COMPLETELY PARALYZED FROM HER CHEST DOWN WITH THE MOTOR-SENSORY LOSS FROM T4 TO HER TOES AND NOW SUFFERS FROM DY

  Patient problems: Injury; Neurological Deficit/Dysfunction; Paralysis; Unspecified Nervous System Problem

  MAUDE report 10045022 ↗
• InjuryMay 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONALLY IT WAS REPORTED THAT ON (B)(6) 2018 PATIENT A SUBSEQUENT REMOVAL OF SPINAL HARDWARE INCLUDING BILATERAL RODS, T2 HOOKS BILATERALLY, RIGHT T5 SCREW AND LEFT T9 AND T10. THIS INTERVENTION WAS NOTED FOR PARTIAL CORRECTION OF PATIENT'S DEFORMITY.

  Patient problems: Injury; Neurological Deficit/Dysfunction; Paralysis; Unspecified Nervous System Problem

  MAUDE report 10044994 ↗
• InjuryMay 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONALLY IT WAS REPORTED THAT ON (B)(6) 2018 PATIENT A SUBSEQUENT REMOVAL OF SPINAL HARDWARE INCLUDING BILATERAL RODS, T2 HOOKS BILATERALLY, RIGHT T5 SCREW AND LEFT T9 AND T10. THIS INTERVENTION WAS NOTED FOR PARTIAL CORRECTION OF PATIENT'S DEFORMITY.

  Patient problems: Neurological Deficit/Dysfunction; Paralysis; Unspecified Nervous System Problem

  MAUDE report 10044993 ↗
• InjuryMay 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONALLY IT WAS REPORTED THAT ON (B)(6) 2018 PATIENT A SUBSEQUENT REMOVAL OF SPINAL HARDWARE INCLUDING BILATERAL RODS, T2 HOOKS BILATERALLY, RIGHT T5 SCREW AND LEFT T9 AND T10. THIS INTERVENTION WAS NOTED FOR PARTIAL CORRECTION OF PATIENT'S DEFORMITY.

  Patient problems: Injury; Neurological Deficit/Dysfunction; Paralysis; Unspecified Nervous System Problem

  MAUDE report 10044988 ↗
• InjuryMay 11, 2020Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT ON (B)(6) 2015, THE PATIENT PRESENTED WITH THE COMPLAINTS OF SHOULDER PAIN WHICH REVEALED SCOLIOSIS OBTAINED ON RADIOLOGICAL STUDIES. HOWEVER, THEY FAILED TO DIAGNOSE SCOLIOSIS OR HAVE THE PATIENT SCOLIOSIS EVALUATION. ON (B)(6) 2018, THE PATIENT CAME WITH THE COMPLAINTS OF UPPER BACK PAIN PRIMARILY IN THE LEFT-MID-THORACIC SPINE RADIATING TO THE LEFT AND RIGHT BUTTOCKS. THE PAIN WAS INTERMITTENT, MODERATE ACHE WITH NO HISTORY OF BACK PAIN BEFORE. ON (B)(6) 2018, THE PATIENT EXPLAINED THAT HE HAD LOW BACK PAIN AND OCCASIONAL THIGH PAIN. THE PATIENT DENIED OF RADIATING PAIN, NUMBNESS OR TINGLING IN HER EXTREMITIES. THE PATIENT WAS SCHEDULED THEN WITH POSTERIOR INSTRUMENTED FUSION T2 TO L4 VERTEBRAL BODIES. THE NEED FOR THE SURGERY WAS URGENT BECAUSE IT WAS NOT DETECTED EARLIER. ON (B)(6) 2018, THE SURGEON RECOMMENDED AND AGREED TO HAVE URGENT SURGERY TO THE PATIENT WITH MORE CONSERVATIVE TREATMENT. ON (B)(6) 2018, THEY BEGAN THE SURGERY (POSTERIOR INSTRUMENTED FUSION T2 TO L4. BUT WHEN THE PATIENT AWOKE FROM THE SURGERY, THE PATIENT WAS COMPLETELY PARALYZED FROM HER CHEST DOWN WITH THE MOTOR-SENSORY LOSS FROM T4 TO HER TOES. AND NOW SUFFERS FROM DYSREFLEXIA. NO

  Patient problems: Neurological Deficit/Dysfunction; Paralysis; Unspecified Nervous System Problem

  MAUDE report 10043116 ↗
• InjuryMay 11, 2020Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT ON (B)(6) 2015, THE PATIENT PRESENTED WITH THE COMPLAINTS OF SHOULDER PAIN WHICH REVEALED SCOLIOSIS OBTAINED ON RADIOLOGICAL STUDIES. HOWEVER, THEY FAILED TO DIAGNOSE SCOLIOSIS OR HAVE THE PATIENT SCOLIOSIS EVALUATION. ON (B)(6) 2018, THE PATIENT CAME WITH THE COMPLAINTS OF UPPER BACK PAIN PRIMARILY IN THE LEFT-MID-THORACIC SPINE RADIATING TO THE LEFT AND RIGHT BUTTOCKS. THE PAIN WAS INTERMITTENT, MODERATE ACHE WITH NO HISTORY OF BACK PAIN BEFORE. ON (B)(6) 2018, THE PATIENT EXPLAINED THAT HE HAD LOW BACK PAIN AND OCCASIONAL THIGH PAIN. THE PATIENT DENIED OF RADIATING PAIN, NUMBNESS OR TINGLING IN HER EXTREMITIES. THE PATIENT WAS SCHEDULED THEN WITH POSTERIOR INSTRUMENTED FUSION T2 TO L4 VERTEBRAL BODIES. THE NEED FOR THE SURGERY WAS URGENT BECAUSE IT WAS NOT DETECTED EARLIER. ON (B)(6) 2018, THE SURGEON RECOMMENDED AND AGREED TO HAVE URGENT SURGERY TO THE PATIENT WITH MORE CONSERVATIVE TREATMENT. ON (B)(6) 2018, THEY BEGAN THE SURGERY (POSTERIOR INSTRUMENTED FUSION T2 TO L4. BUT WHEN THE PATIENT AWOKE FROM THE SURGERY, THE PATIENT WAS COMPLETELY PARALYZED FROM HER CHEST DOWN WITH THE MOTOR-SENSORY LOSS FROM T4 TO HER TOES AND NOW SUFFERS FROM DYSREFLEXIA. NO F

  Patient problems: Neurological Deficit/Dysfunction; Paralysis; Unspecified Nervous System Problem

  MAUDE report 10043106 ↗
• InjuryMay 11, 2020Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  ADDITIONALLY IT WAS REPORTED THAT ON (B)(6) 2018 PATIENT A SUBSEQUENT REMOVAL OF SPINAL HARDWARE INCLUDING BILATERAL RODS, T2 HOOKS BILATERALLY, RIGHT T5 SCREW AND LEFT T9 AND T10. THIS INTERVENTION WAS NOTED FOR PARTIAL CORRECTION OF PATIENT'S DEFORMITY.

  Patient problems: Neurological Deficit/Dysfunction; Paralysis; Unspecified Nervous System Problem

  MAUDE report 10043097 ↗
• InjuryMay 11, 2020Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  ADDITIONALLY IT WAS REPORTED THAT ON (B)(6) 2018 PATIENT A SUBSEQUENT REMOVAL OF SPINAL HARDWARE INCLUDING BILATERAL RODS, T2 HOOKS BILATERALLY, RIGHT T5 SCREW AND LEFT T9 AND T10. THIS INTERVENTION WAS NOTED FOR PARTIAL CORRECTION OF PATIENT'S DEFORMITY.

  Patient problems: Neurological Deficit/Dysfunction; Paralysis; Unspecified Nervous System Problem

  MAUDE report 10043092 ↗