NA 498.003Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10705034788579), received between Nov 30, 2017 and Dec 5, 2019 — classified as 13 injuries.

The most frequently reported specific device problem is “Unintended Movement” (2 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryDec 5, 2019Device Slipped; Device Slipped

  IT WAS REPORTED ON (B)(6) 2019, THE PATIENT UNDERWENT REVISION OF UNIVERSAL SPINAL SYSTEM (USS) SYNTHES DEVICES DUE TO AN UNKNOWN POINT IN TIME THE LEFT L2 NUT AND COLLAR CAME OFF OF THE SCREW.

  Patient problems: No Code Available

  MAUDE report 9417947 ↗
• InjurySep 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT HAD AN L4-ILIUM POSTERIOR SPINAL FUSION WITH SYNTHES UNIVERSAL SPINAL SYSTEM (USS). AT AN UNKNOWN TIME, THE PATIENT DEVELOPED BACK PAIN, AND ALSO AN ADJACENT LEVEL DISC DISEASE ABOVE THE FUSION. THE SURGEON PERFORMED THE REVISION SURGERY ON (B)(6) 2018, THEN REMOVED ALL THE NUTS, COLLARS, AND BOTH RODS. WHILE REMOVING THE RODS, THE SURGEON DISCOVERED THAT THE LEFT ROD WAS BROKEN JUST CRANIAL TO THE LEFT S1 SCREW. THE SURGEON PLACED A NEW USS SCREWS AT L2 AND L3, AND CONTOURED NEW RODS, AND CONNECTED THEM TO THE SCREWS FROM L2-ILIUM. THE SURGEON DID NOT REPLACE ANY OF THE L4-ILIUM SCREWS FROM THE (B)(6) 2018 SURGERY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO SURGICAL DELAY AND PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS REPORT IS 6 OF 7 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 7916476 ↗
• InjurySep 10, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT HAD A T11-L3 POSTERIOR SPINAL FUSION WITH SYNTHES UNIVERSAL SPINAL SYSTEM (USS) (NO SCREWS IN L1 - PEDICLE SUBTRACTION OSTEOTOMY LEVEL). ACCORDING TO THE SURGEON SAID THAT THE PATIENT HAD BEEN EXPERIENCING INCREASING PAIN IN THE PAST MONTH. AT AN UNKNOWN TIME, THE L3 SCREWS SLID OFF THE ROD CAUDALLY. ON (B)(6) 2018, THE SURGEON PERFORMED THE REVISION SURGERY. HE REMOVED BOTH OF THE 6.0 X 125MM RODS. HE THEN REPLACED THE L3 7.0 X 55MM USS SCREWS WITH 8.0 X 55MM SCREWS. THE EXISTING SCREWS WERE SLIGHTLY LOOSE IN THE BONE. HE THEN SELECTED 6.0 X 150MM RODS AND CONNECTED THEM TO THE SCREWS. HE FINAL TIGHTENED ALL THE NUTS AND SUCCESSFULLY COMPLETED THE PROCEDURE. CONCOMITANT DEVICES REPORTED: TITANIUM HARD ROD (PART 498.105, LOT NUMBER UNKNOWN, QUANTITY 2), TITANIUM COLLAR (PART 498.010, LOT NUMBER UNKNOWN, QUANTITY 2), TITANIUM SIDE-OPENING SCREW (PART 498.755, LOT NUMBER UNKNOWN, QUANTITY 2). THIS REPORT IS FOR ONE (1) TITANIUM NUT. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7862304 ↗
• InjurySep 10, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT HAD A T11-L3 POSTERIOR SPINAL FUSION WITH SYNTHES UNIVERSAL SPINAL SYSTEM (USS) (NO SCREWS IN L1 - PEDICLE SUBTRACTION OSTEOTOMY LEVEL). ACCORDING TO THE SURGEON SAID THAT THE PATIENT HAD BEEN EXPERIENCING INCREASING PAIN IN THE PAST MONTH. AT AN UNKNOWN TIME, THE L3 SCREWS SLID OFF THE ROD CAUDALLY. ON (B)(6) 2018, THE SURGEON PERFORMED THE REVISION SURGERY. HE REMOVED BOTH OF THE 6.0 X 125MM RODS. HE THEN REPLACED THE L3 7.0 X 55MM USS SCREWS WITH 8.0 X 55MM SCREWS. THE EXISTING SCREWS WERE SLIGHTLY LOOSE IN THE BONE. HE THEN SELECTED 6.0 X 150MM RODS AND CONNECTED THEM TO THE SCREWS. HE FINAL TIGHTENED ALL THE NUTS AND SUCCESSFULLY COMPLETED THE PROCEDURE. CONCOMITANT DEVICES REPORTED: TITANIUM HARD ROD (PART 498.105, LOT NUMBER UNKNOWN, QUANTITY 2), TITANIUM COLLAR (PART 498.010, LOT NUMBER UNKNOWN, QUANTITY 2), TITANIUM SIDE-OPENING SCREW (PART 498.755, LOT NUMBER UNKNOWN, QUANTITY 2). THIS REPORT IS FOR ONE (1) TITANIUM NUT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7862288 ↗
• InjurySep 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SURGERY WAS PERFORMED ON (B)(6) 2008, FOR TREATMENT A L5 POSTERIOR RESECTION DUE TO A HEMANGIOMA WITH A L4-S1 POSTERIOR FUSION. DURING THIS PROCEDURE, THE PATIENT WAS IMPLANTED WITH THE (USS) UNIVERSAL SPINE SYSTEM IMPLANTS. THE PATIENT WAS IMPLANTED WITH ONE (1) 6.0MM/ 200MM TI ROD THAT WAS CUT IN HALF TO CONSTRUCT TWO RODS, TWO (2) TI LOW PROFILE TRANS-CONNECTORS, FOUR (4) NUTS, FOUR (4) COLLARS, TWO (2)8MM X 55MM SCREWS AND TWO (2) 9MM X 50MM SCREWS. ON (B)(6) 2008 PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM FOR A FOLLOW-UP PROCEDURE, WHERE THE PATIENT WAS IMPLANTED WITH ONE (1) SYNEX CAGE IMPLANT AT THE L5 SPINE DISC SPACE LEVEL. POST-OPERATIVE, THE PATIENT PRESENTED WITH A LUMBAR SPINE INFECTION. ON (B)(6) 2008, SURGEON PERFORMED AN IRRIGATION AND DEBRIDEMENT PROCEDURE TO ADDRESS THE PATIENT'S INFECTION. NO PUS WAS FOUND INTRAOPERATIVELY. TISSUES APPEARED HEALTHY. CULTURES TAKEN DURING SURGERY WERE REPORTED WITH NO ORGANISMS SEEN ON GRAM STAIN. SURGERY WAS COMPLETED SUCCESSFULLY. THIS IS REPORT 4 OF 8 FOR (B)(4). THE ADDITIONAL 8 PARTS ARE BEING CAPTURED ON RELATED COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7856907 ↗
• InjurySep 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SURGERY WAS PERFORMED ON (B)(6) 2008, FOR TREATMENT A L5 POSTERIOR RESECTION DUE TO A HEMANGIOMA WITH A L4-S1 POSTERIOR FUSION. DURING THIS PROCEDURE, THE PATIENT WAS IMPLANTED WITH THE (USS) UNIVERSAL SPINE SYSTEM IMPLANTS. THE PATIENT WAS IMPLANTED WITH ONE (1) 6.0MM/ 200MM TI ROD THAT WAS CUT IN HALF TO CONSTRUCT TWO RODS, TWO (2) TI LOW PROFILE TRANS-CONNECTORS, FOUR (4) NUTS, FOUR (4) COLLARS, TWO (2) 8MM X 55MM SCREWS AND TWO (2) 9MM X 50MM SCREWS. ON (B)(6) 2008 PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM FOR A FOLLOW-UP PROCEDURE, WHERE THE PATIENT WAS IMPLANTED WITH ONE (1) SYNEX CAGE IMPLANT AT THE L5 SPINE DISC SPACE LEVEL. POST-OPERATIVE, THE PATIENT PRESENTED WITH A LUMBAR SPINE INFECTION. ON (B)(6) 2008, SURGEON PERFORMED AN IRRIGATION AND DEBRIDEMENT PROCEDURE TO ADDRESS THE PATIENT'S INFECTION. NO PUS WAS FOUND INTRAOPERATIVELY. TISSUES APPEARED HEALTHY. CULTURES TAKEN DURING SURGERY WERE REPORTED WITH NO ORGANISMS SEEN ON GRAM STAIN. SURGERY WAS COMPLETED SUCCESSFULLY. THIS IS REPORT 2 OF 8 FOR (B)(4). THE ADDITIONAL 8 PARTS ARE BEING CAPTURED ON RELATED COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7856882 ↗
• InjurySep 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SURGERY WAS PERFORMED ON (B)(6) 2008, FOR TREATMENT A L5 POSTERIOR RESECTION DUE TO A HEMANGIOMA WITH A L4-S1 POSTERIOR FUSION. DURING THIS PROCEDURE, THE PATIENT WAS IMPLANTED WITH THE (USS) UNIVERSAL SPINE SYSTEM IMPLANTS. THE PATIENT WAS IMPLANTED WITH ONE (1) 6.0MM/ 200MM TI ROD THAT WAS CUT IN HALF TO CONSTRUCT TWO RODS, TWO (2) TI LOW PROFILE TRANS-CONNECTORS, FOUR (4) NUTS, FOUR (4) COLLARS, TWO (2) 8MM X 55MM SCREWS AND TWO (2) 9MM X 50MM SCREWS. ON (B)(6) 2008 PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM FOR A FOLLOW-UP PROCEDURE, WHERE THE PATIENT WAS IMPLANTED WITH ONE (1) SYNEX CAGE IMPLANT AT THE L5 SPINE DISC SPACE LEVEL. POST-OPERATIVE, THE PATIENT PRESENTED WITH A LUMBAR SPINE INFECTION. ON (B)(6) 2008, SURGEON PERFORMED AN IRRIGATION AND DEBRIDEMENT PROCEDURE TO ADDRESS THE PATIENT'S INFECTION. NO PUS WAS FOUND INTRAOPERATIVELY. TISSUES APPEARED HEALTHY. CULTURES TAKEN DURING SURGERY WERE REPORTED WITH NO ORGANISMS SEEN ON GRAM STAIN. SURGERY WAS COMPLETED SUCCESSFULLY. THIS IS REPORT 1 OF 8 FOR (B)(4). THE ADDITIONAL 8 PARTS ARE BEING CAPTURED ON RELATED COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7856825 ↗
• InjuryDec 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HARDWARE REMOVAL AND REVISION PROCEDURE OF TWO (2) NUTS, TWO (COLLARS), AND TWO (2) SCREWS BELONGING TO SYNTHES USS CONSTRUCT FROM L2 VERTEBRA ON (B)(6) 2017. TWO (2) INITIALLY IMPLANTED CAUDAL RODS WERE LEFT IN THE PATIENT AND CONNECTED TO NEW RODS USING ROD TO ROD CONNECTORS. THE PATIENT HAD A L2-ILIUM POSTERIOR FUSION WITH SYNTHES USS IN (B)(6) 2016. THE PATIENT IS REPORTED TO HAVE INCREASING BACK PAIN SINCE THE TIME OF THE INITIAL FUSION PROCEDURE, POSSIBLY DUE TO DEGENERATIVE DISC DISEASE AND STENOSIS ABOVE THE LEVELS OF THE (B)(6) 2016 FUSION PROCEDURE. AFTER REMOVING THE NUTS, COLLARS AND SCREWS FROM L2 VERTEBRA BILATERALLY, THE SURGEON INSERTED ROD TO ROD CONNECTORS ON THE EXISTING RODS AT L2 FOLLOWED BY PLACING NEW SCREWS AT T10, T11, T12 AND L1. THE SURGEON THEN CONNECTED THE EXISTING CAUDAL RODS TO THE NEW CRANIAL RODS WITH THE ROD TO ROD CONNECTORS BILATERALLY, THUS CONCLUDING THE PROCEDURE. THE REMOVAL AND REVISION PROCEDURE WAS COMPLETED SUCCESSFULLY AND UNEVENTFULLY WITH NO ADDITIONAL INTERVENTIONS REQUIRED. THE PATIENT IS REPORTED TO BE IN STABLE CONDITION. THIS IS REPORT 4 OF 6 FOR(B)(6).

  Patient problems: No Code Available; Pain; Stenosis

  MAUDE report 7088600 ↗
• InjuryDec 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HARDWARE REMOVAL AND REVISION PROCEDURE OF TWO (2) NUTS, TWO (COLLARS), AND TWO (2) SCREWS BELONGING TO SYNTHES USS CONSTRUCT FROM L2 VERTEBRA ON (B)(6) 2017. TWO (2) INITIALLY IMPLANTED CAUDAL RODS WERE LEFT IN THE PATIENT AND CONNECTED TO NEW RODS USING ROD TO ROD CONNECTORS. THE PATIENT HAD A L2-ILIUM POSTERIOR FUSION WITH SYNTHES USS IN (B)(6) 2016. THE PATIENT IS REPORTED TO HAVE INCREASING BACK PAIN SINCE THE TIME OF THE INITIAL FUSION PROCEDURE, POSSIBLY DUE TO DEGENERATIVE DISC DISEASE AND STENOSIS ABOVE THE LEVELS OF THE (B)(6) 2016 FUSION PROCEDURE. AFTER REMOVING THE NUTS, COLLARS AND SCREWS FROM L2 VERTEBRA BILATERALLY, THE SURGEON INSERTED ROD TO ROD CONNECTORS ON THE EXISTING RODS AT L2 FOLLOWED BY PLACING NEW SCREWS AT T10, T11, T12 AND L1. THE SURGEON THEN CONNECTED THE EXISTING CAUDAL RODS TO THE NEW CRANIAL RODS WITH THE ROD TO ROD CONNECTORS BILATERALLY, THUS CONCLUDING THE PROCEDURE. THE REMOVAL AND REVISION PROCEDURE WAS COMPLETED SUCCESSFULLY AND UNEVENTFULLY WITH NO ADDITIONAL INTERVENTIONS REQUIRED. THE PATIENT IS REPORTED TO BE IN STABLE CONDITION. THIS IS REPORT 2 OF 6 FOR (B)(4).

  Patient problems: No Code Available; Pain; Stenosis

  MAUDE report 7088500 ↗
• InjuryNov 30, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A SPINAL FUSION ON (B)(6) 2002 DUE TO SPONDYLOLYTIC SPONDYLOLISTHESIS AND LUMBOSACRAL NEURITIS AND UNDERWENT AN ANTERIOR AND POSTERIOR SPINAL FUSION WITH INSTRUMENTATION AND AUTOGENOUS BONE GRAFT ALONG WITH A FEMORAL RING ALLOGRAFT AND A GILL TYPE PROCEDURE. IMPLANTS INCLUDED UNIVERSAL SPINE SYSTEM (USS); THREE (3) 45MM SIDE-OPENING SCREWS, ONE (1) 50MM SIDE-OPENING SCREW, FOUR (4) 11MM NUTS, FOUR (4) COLLAR WITH GROOVES AND TWO (2) 6.0MM RODS. OTHER IMPLANTS INCLUDED; ONE (1) FRA BONE GRAFT, SIZE 5, ONE (1) CERVICAL SPINE LOCKING PLATE 34MM, FOUR (4) 4.35MM EXPANSIONHEAD SCREWS 25MM AND FOUR (4) 1.8MM LOCKING SCREWS. PATIENT WAS IMPROVING AND HARDWARE WAS IN PLACE IN (B)(6) 2003. ON (B)(6) 2003, A CAT SCAN WAS PERFORMED ON THE LUMBAR SPINE AND DEGENERATIVE CHANGES WERE NOTED. THE PATIENT RETURNED TO HOSPITAL ON (B)(6) 2003 AND (B)(6) 2003 DUE TO SPONDYLOLISTHESIS, PAIN, NUMBNESS AND SWELLING IN BOTH LEGS AND HAD DISCOGRAM INJECTIONS TO THE LUMBAR SPINE. ON (B)(6)2003, THE PATIENT INJURED HIS LOWER BACK AT WORK AND RETURNED TO THE HOSPITAL ON (B)(6) 2003 FOR BACK PAIN AND SPONDYLOLISTHESIS. ON (B)(6) 2004, THE PATIENT UNDERWENT A REVISION AT L5

  Patient problems: Hypoesthesia; Pain; Weakness

  MAUDE report 7072406 ↗
• InjuryNov 30, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A SPINAL FUSION ON (B)(6) 2002 DUE TO SPONDYLOLYTIC SPONDYLOLISTHESIS AND LUMBOSACRAL NEURITIS AND UNDERWENT AN ANTERIOR AND POSTERIOR SPINAL FUSION WITH INSTRUMENTATION AND AUTOGENOUS BONE GRAFT ALONG WITH A FEMORAL RING ALLOGRAFT AND A GILL TYPE PROCEDURE. IMPLANTS INCLUDED UNIVERSAL SPINE SYSTEM (USS); THREE (3) 45 MM SIDE-OPENING SCREWS, ONE (1) 50 MM SIDE-OPENING SCREW, FOUR (4) 11 MM NUTS, FOUR (4) COLLAR WITH GROOVES AND TWO (2) 6.0 MM RODS. OTHER IMPLANTS INCLUDED; ONE (1) FRA BONE GRAFT, SIZE 5, ONE (1) CERVICAL SPINE LOCKING PLATE 34 MM, FOUR (4) 4.35 MM EXPANSIONHEAD SCREWS 25 MM AND FOUR (4) 1.8 MM LOCKING SCREWS. PATIENT WAS IMPROVING AND HARDWARE WAS IN PLACE IN (B)(6) 2003. ON (B)(6) 2003, A CAT SCAN WAS PERFORMED ON THE LUMBAR SPINE AND DEGENERATIVE CHANGES WERE NOTED. THE PATIENT RETURNED TO HOSPITAL ON (B)(6) 2003 DUE TO SPONDYLOLISTHESIS, PAIN, NUMBNESS AND SWELLING IN BOTH LEGS AND HAD DISCOGRAM INJECTIONS TO THE LUMBAR SPINE. ON (B)(6) 2003, THE PATIENT INJURED HIS LOWER BACK AT WORK AND RETURNED TO THE HOSPITAL ON (B)(6) 2003 FOR BACK PAIN AND SPONDYLOLISTHESIS. ON (B)(6) 2004, THE PATIENT UNDERWENT A REVISION AT L5-S1 DUE

  Patient problems: Hypoesthesia; Pain; Weakness

  MAUDE report 7071960 ↗
• InjuryNov 30, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A SPINAL FUSION ON (B)(6) 2002 DUE TO SPONDYLOLYTIC SPONDYLOLISTHESIS AND LUMBOSACRAL NEURITIS AND UNDERWENT AN ANTERIOR AND POSTERIOR SPINAL FUSION WITH INSTRUMENTATION AND AUTOGENOUS BONE GRAFT ALONG WITH A FEMORAL RING ALLOGRAFT AND A GILL TYPE PROCEDURE. IMPLANTS INCLUDED UNIVERSAL SPINE SYSTEM (USS); THREE (3) 45MM SIDE-OPENING SCREWS, ONE (1) 50MM SIDE-OPENING SCREW, FOUR (4) 11MM NUTS, FOUR (4) COLLAR WITH GROOVES AND TWO (2) 6.0MM RODS. OTHER IMPLANTS INCLUDED; ONE (1) FRA BONE GRAFT, SIZE 5, ONE (1) CERVICAL SPINE LOCKING PLATE 34MM, FOUR (4) 4.35MM EXPANSIONHEAD SCREWS 25MM AND FOUR (4) 1.8MM LOCKING SCREWS. PATIENT WAS IMPROVING AND HARDWARE WAS IN PLACE IN (B)(6) 2003. ON (B)(6) 2003, A CAT SCAN WAS PERFORMED ON THE LUMBAR SPINE AND DEGENERATIVE CHANGES WERE NOTED. THE PATIENT RETURNED TO HOSPITAL ON (B)(6) 2003 AND (B)(6) 2003 DUE TO SPONDYLOLISTHESIS, PAIN, NUMBNESS AND SWELLING IN BOTH LEGS AND HAD DISCOGRAM INJECTIONS TO THE LUMBAR SPINE. ON (B)(6) 2003, THE PATIENT INJURED HIS LOWER BACK AT WORK AND RETURNED TO THE HOSPITAL ON (B)(6) 2003 FOR BACK PAIN AND SPONDYLOLISTHESIS. ON (B)(6) 2004, THE PATIENT UNDERWENT A REVISION AT L

  Patient problems: Hypoesthesia; Pain; Weakness

  MAUDE report 7071955 ↗
• InjuryNov 30, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A SPINAL FUSION ON (B)(6) 2002 DUE TO SPONDYLOLYTIC SPONDYLOLISTHESIS AND LUMBOSACRAL NEURITIS AND UNDERWENT AN ANTERIOR AND POSTERIOR SPINAL FUSION WITH INSTRUMENTATION AND AUTOGENOUS BONE GRAFT ALONG WITH A FEMORAL RING ALLOGRAFT AND A GILL TYPE PROCEDURE. IMPLANTS INCLUDED UNIVERSAL SPINE SYSTEM (USS); THREE (3) 45MM SIDE-OPENING SCREWS, ONE (1) 50MM SIDE-OPENING SCREW, FOUR (4) 11MM NUTS, FOUR (4) COLLAR WITH GROOVES AND TWO (2) 6.0MM RODS. OTHER IMPLANTS INCLUDED; ONE (1) FRA BONE GRAFT, SIZE 5, ONE (1) CERVICAL SPINE LOCKING PLATE 34MM, FOUR (4) 4.35MM EXPANSIONHEAD SCREWS 25MM AND FOUR (4) 1.8MM LOCKING SCREWS. PATIENT WAS IMPROVING AND HARDWARE WAS IN PLACE IN (B)(6) 2003. ON (B)(6) 2003, A CAT SCAN WAS PERFORMED ON THE LUMBAR SPINE AND DEGENERATIVE CHANGES WERE NOTED. THE PATIENT RETURNED TO HOSPITAL ON (B)(6) 2003 AND (B)(6), 2003 DUE TO SPONDYLOLISTHESIS, PAIN, NUMBNESS AND SWELLING IN BOTH LEGS AND HAD DISCOGRAM INJECTIONS TO THE LUMBAR SPINE. ON (B)(6)2003, THE PATIENT INJURED HIS LOWER BACK AT WORK AND RETURNED TO THE HOSPITAL ON (B)(6) 2003 FOR BACK PAIN AND SPONDYLOLISTHESIS. ON (B)(6) 2004, THE PATIENT UNDERWENT A REVISION AT L

  Patient problems: Hypoesthesia; Pain; Weakness

  MAUDE report 7071691 ↗