NA 498.011Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10705034788593), received between Jul 24, 2017 and May 22, 2025 — classified as 11 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryMay 22, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, SURGEON PERFORMED A TRANSFORAMINAL LUMBAR INTERBODY FUSION ON PATIENT USING THE USS SYSTEM. POSTOPERATIVE X-RAY EXAMINATION SHOWED A TITANIUM COLLAR FRAGMENT CHIPPED OFF AND LOOSE IN THE PATIENT. SPECIFIC LEVEL WAS L1, PATIENT¿S LEFT SIDE. PATIENT WENT IN FOR REVISION ON (B)(6) 2025 TO GET LOOSE FRAGMENT REMOVED AND REPLACED.

  Patient problems: Insufficient Information

  MAUDE report 22073419 ↗
• InjuryOct 17, 2018Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2018 DUE TO (2) BROKEN USS SLEEVES. THE PATIENT WAS ORIGINALLY OPERATED WITH A FIXATION OF THE SACRUM-LUMBAR SPINE (L4-L5-S1) ON (B)(6) 2018, USING MATERIALS OF SWISS ORIGIN. TWO MONTHS AFTER THE SURGERY, THE PATIENT HAD A RADIOLOGICAL CHECK SHOWING THE RUPTURE OF THE USS SLEEVES FOR THE USS PEDICLE SCREWS THAT FIX THE TITANIUM HARD ROD TO THE SPINE. NO FALL, SUDDEN MOVEMENT, OR IMPRUDENCE WAS COMMITTED IN THE INTERVAL. ALSO NO ACUTE PAIN THAT WAS INSINUATED SUCH A FACT, WAS PERCEIVED. WHEN THE ISSUE WAS NOTICED, THE SURGEON SENT THE PATIENT TO OPERATION TO MAKE THE NECESSARY ADJUSTMENTS. DURING SURGERY, THEY FOUND THE (2) USS SLEEVES BROKEN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. PATIENT OUTCOME WAS STABLE. CONCOMITANT DEVICES REPORTED: USS PEDICLE SCREW, SIDE-OPENING (PART #: 498.650, LOT #: UNKNOWN, QUANTITY: UNKNOWN). TITANIUM HARD ROD (PART #: 498.106, LOT #: UNKNOWN, QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) TI COLLAR WITH GROOVES. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7974425 ↗
• InjuryOct 17, 2018Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2018 DUE TO (2) BROKEN USS SLEEVES. THE PATIENT WAS ORIGINALLY OPERATED WITH A FIXATION OF THE SACRUM-LUMBAR SPINE (L4-L5-S1) ON (B)(6) 2018, USING MATERIALS OF SWISS ORIGIN. TWO MONTHS AFTER THE SURGERY, THE PATIENT HAD A RADIOLOGICAL CHECK SHOWING THE RUPTURE OF THE USS SLEEVES FOR THE USS PEDICLE SCREWS THAT FIX THE TITANIUM HARD ROD TO THE SPINE. NO FALL, SUDDEN MOVEMENT, OR IMPRUDENCE WAS COMMITTED IN THE INTERVAL. ALSO NO ACUTE PAIN THAT WAS INSINUATED SUCH A FACT, WAS PERCEIVED. WHEN THE ISSUE WAS NOTICED, THE SURGEON SENT THE PATIENT TO OPERATION TO MAKE THE NECESSARY ADJUSTMENTS. DURING SURGERY, THEY FOUND THE (2) USS SLEEVES BROKEN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. PATIENT OUTCOME WAS STABLE. CONCOMITANT DEVICES REPORTED: USS PEDICLE SCREW, SIDE-OPENING (PART #: 498.650, LOT #: UNKNOWN, QUANTITY: UNKNOWN), TITANIUM HARD ROD (PART #: 498.106, LOT #: UNKNOWN, QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) TI COLLAR WITH GROOVES. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7974418 ↗
• InjurySep 11, 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 8 OF 8 FOR (B)(4). THE ADDITIONAL 8 PARTS ARE BEING CAPTURED ON RELATED COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7863619 ↗
• InjurySep 11, 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 7 OF 8 FOR (B)(4). THE ADDITIONAL 8 PARTS ARE BEING CAPTURED ON RELATED COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7863611 ↗
• InjurySep 11, 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 MARCH 14, 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 6 OF 8 FOR (B)(4). THE ADDITIONAL 8 PARTS ARE BEING CAPTURED ON RELATED COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7863609 ↗
• InjurySep 11, 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 5 OF 8 FOR (B)(4). THE ADDITIONAL 8 PARTS ARE BEING CAPTURED ON RELATED COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7863608 ↗
• MalfunctionMar 8, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING AN UNKNOWN SPINE PROCEDURE ON (B)(6) 2018, AS SURGEON WAS ATTEMPTING TO ADJUST THE TITANIUM COLLAR WITH GROOVES THE DEVICE BROKE. THIS DELAYED SURGERY BY APPROXIMATELY 20 MINUTES. PROCEDURE WAS COMPLETED WITH NO REPORTED HARM TO THE PATIENT. THIS REPORT IS FOR ONE (1) TITANIUM COLLAR WITH GROOVES. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7325106 ↗
• MalfunctionMar 8, 2018Break; Break

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING FIXATION AND ARTHRODESIS OF TRAUMATIC LUMBAR SPINE PROCEDURE ON (B)(6) 2018, WHEN THE SURGEON WAS INSERTING THE TITANIUM COLLAR WITH GROOVES, IT WAS BROKEN AFTER BEING ADJUSTED. THE COLLAR WAS IMMEDIATELY REPLACED WITH ANOTHER ONE. THIS DELAYED SURGERY BY APPROXIMATELY 30 MINUTES. PROCEDURE WAS COMPLETED SUCCESSFULLY AND PATIENT WAS REPORTED AS STABLE. THIS REPORT IS FOR ONE (1) TITANIUM COLLAR WITH GROOVES. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7324916 ↗
• MalfunctionMar 1, 2018Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A LUMBAR CORPECTOMY WITH AUTOLOGOUS BONE GRAFT AND ARTHRODESIS USING THE UNIVERSAL SPINAL SYSTEM MONOAXIAL SCREWS ON (B)(6) 2018, TWO TITANIUM COLLARS WITH GROOVES WERE BROKEN DURING THE PROCEDURE CAUSING AN APPROXIMATE 30-MINUTE DELAY IN THE PROCEDURE. THERE WAS REPORTEDLY NO HARM TO THE PATIENT. THE SURGERY WAS COMPLETED USING A SIMILAR DEVICE. THE BROKEN DEVICES HAVE BEEN DISCARDED, AS SUCH, THEY ARE NOT AVAILABLE FOR INVESTIGATION. (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7307918 ↗
• MalfunctionMar 1, 2018Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A LUMBAR CORPECTOMY WITH AUTOLOGOUS BONE GRAFT AND ARTHRODESIS USING THE UNIVERSAL SPINAL SYSTEM MONOAXIAL SCREWS ON (B)(6) 2018, TWO TITANIUM COLLARS WITH GROOVES WERE BROKEN DURING THE PROCEDURE CAUSING AN APPROXIMATE 30-MINUTE DELAY IN THE PROCEDURE. THERE WAS REPORTEDLY NO HARM TO THE PATIENT. THE SURGERY WAS COMPLETED USING A SIMILAR DEVICE. THE BROKEN DEVICES HAVE BEEN DISCARDED, AS SUCH, THEY ARE NOT AVAILABLE FOR INVESTIGATION. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7307917 ↗
• 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 EXPANSION HEAD 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 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 TO LOW

  Patient problems: Hypoesthesia; Pain; Weakness

  MAUDE report 7072233 ↗
• 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 7072219 ↗
• 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 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 TO LOWE

  Patient problems: Hypoesthesia; Pain; Weakness

  MAUDE report 7072215 ↗
• 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 7072077 ↗
• MalfunctionJul 24, 2017Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT THREE DEVICES MALFUNCTIONED DURING A T4-L2 SCOLIOSIS PROCEDURE ON (B)(6) 2017. DURING THE PROCEDURE, A HOOK POSITIONER HAD A CHUNK COME OUT OF THE PHENOLIC HANDLE DURING MALLETING. THE CHUNK WAS RECOVERED EASILY. LATER, A SOCKET WRENCH WITH STRAIGHT HANDLE SPLIT INTO TWO PIECES DURING MALLETING. ALL PIECES WERE RECOVERED. FINALLY, UPON FINAL TIGHTENING, THE SURGEON NOTICED THAT A TITANIUM (TI) COLLAR WITH GROOVES AT T8 LEFT WAS BROKEN TOWARD THE END OF THE PROCEDURE. THE BROKEN DEVICE WAS EASILY AND QUICKLY REMOVED AND ANOTHER COLLAR WAS IMPLANTED. THE PROCEDURE WAS COMPLETED WITH NO PATIENT HARM. CONCOMITANT DEVICES REPORTED: TITANIUM NUT 11MM WIDTH ACROSS FLATS (PART 498.003, LOT NUMBER UNKNOWN, QUANTITY 1); 5.0MM TITANIUM SIDE-OPENING SCREW 35MM (PART 498.535, LOT NUMBER UNKNOWN, QUANTITY 1); MALLET (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) TITANIUM COLLAR WITH GROOVES. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6737157 ↗