NA 497.78Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705034788340), received between Nov 30, 2017 and Mar 2, 2023 — classified as 8 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMar 2, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN CANADA AS FOLLOWS: AFTER A CORPECTOMY COMPLETED ON (B)(6) 2023, THE IMPLANT BECAME DISPLACED AND THE SUPERIOR PORTION OF THE CONSTRUCT SLIPPED FORWARD. THIS PATIENT REQUIRED A REVISION SURGERY COMPLETED ON (B)(6) 2023 WHERE NEW IMPLANTS WERE USED. THE PATIENT REQUIRES REVISION SURGERY OR HARDWARE REMOVAL. HARDWARE/EXPLANT REMOVAL DUE TO: --IMPLANT EXPULSION THROUGH LOCKING PLATE., PATIENT HAD REVISION SURGERY ON (B)(6) 2023 THERE WAS OUTCOME/CONSEQUENCES. PATIENT HAD INFECTION. THERE WERE OTHER MEDICAL INTERVENTION; REVISION SURGERY, CT AND X-RAYS. THERE IS NO INFORMATION. THIS REPORT IS FOR ONE (1)1.8MM TI LOCKING SCREW THIS IS REPORT 8 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 16470606 ↗
• InjuryMar 2, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN CANADA AS FOLLOWS: AFTER A CORPECTOMY COMPLETED ON (B)(6) 2023, THE IMPLANT BECAME DISPLACED AND THE SUPERIOR PORTION OF THE CONSTRUCT SLIPPED FORWARD. THIS PATIENT REQUIRED A REVISION SURGERY COMPLETED ON (B)(6) 2023 WHERE NEW IMPLANTS WERE USED. THE PATIENT REQUIRES REVISION SURGERY OR HARDWARE REMOVAL. HARDWARE/EXPLANT REMOVAL DUE TO: --IMPLANT EXPULSION THROUGH LOCKING PLATE., PATIENT HAD REVISION SURGERY ON (B)(6) 2023 THERE WAS OUTCOME/CONSEQUENCES. PATIENT HAD INFECTION. THERE WERE OTHER MEDICAL INTERVENTION; REVISION SURGERY, CT AND X-RAYS. THERE IS NO INFORMATION. THIS REPORT IS FOR ONE (1)1.8MM TI LOCKING SCREW THIS IS REPORT 6 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 16470525 ↗
• InjuryMar 2, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: AFTER A CORPECTOMY COMPLETED ON (B)(6) 2023, THE IMPLANT BECAME DISPLACED AND THE SUPERIOR PORTION OF THE CONSTRUCT SLIPPED FORWARD. THIS PATIENT REQUIRED A REVISION SURGERY COMPLETED ON (B)(6) 2023 WHERE NEW IMPLANTS WERE USED. THE PATIENT REQUIRES REVISION SURGERY OR HARDWARE REMOVAL. HARDWARE/EXPLANT REMOVAL DUE TO: -- IMPLANT EXPULSION THROUGH LOCKING PLATE, PATIENT HAD REVISION SURGERY ON (B)(6) 2023. THERE WAS OUTCOME/CONSEQUENCES. PATIENT HAD INFECTION. THERE WERE OTHER MEDICAL INTERVENTION; REVISION SURGERY, CT AND X-RAYS. THERE IS NO INFORMATION. THIS REPORT IS FOR ONE (1)1.8MM TI LOCKING SCREW THIS IS REPORT 4 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 16470472 ↗
• InjuryAug 16, 2019Migration; Migration

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN POSTOPERATIVE DATE, THE LOWER SCREW IN CERVICAL SPINE LOCKING PLATE WITH VARIABLE ANGLE (CSLP VA) PLATE HAD BACKED OFF. THE LOCKING SCREW WAS STILL INTACT WITH THE EXPANSION HEAD OF THE 16 MM 4.0 MM SCREW. IT WAS CONFIRMED THAT THE LOCKING CLIP ON THE PLATE WAS ORIENTATED CORRECTLY. THE PATIENT HAD TO BE REVISED TO REMOVE THE BACKED OUT SCREW. DETAILS OF THE REVISION PROCEDURE ARE UNKNOWN. THIS REPORT IS FOR A 1.8 MM TI LOCKING SCREW 5 MM. CONCOMITANT DEVICES: CSLP VA PLATE (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8900825 ↗
• InjuryDec 1, 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

  Patient problems: Hypoesthesia; Pain; Weakness

  MAUDE report 7074332 ↗
• 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 7072990 ↗
• 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 7072927 ↗
• 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 7072894 ↗