NA 04.201.024Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034733845), received between May 7, 2018 and May 7, 2018 — classified as 2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 7, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THE PATIENT UNDERWENT A REVISION ON (B)(6) 2018 DUE TO BACK AND LEG PAIN, SPONDYLOLISTHESIS, AND A PLATE WITH TWO (2) 6 X 24 SCREWS THAT HAD PULLED-OUT FROM THE S1 VERTEBRAL BODY. THE PATIENT WAS INITIALLY IMPLANTED WITH ONE (1) ANTEGRA-T PLATE, TWO (2) 6.0MM/24MM SCREWS, ONE (1) 6.0MM/26MM SCREW, AND ONE (1) 6.5MM/26MM SCREWS. TWO WEEKS POST-OPERATIVELY FROM AN ANTERIOR LUMBAR INTERBODY FUSION SPINAL (ALIF) AT L5-S1, THE PATIENT GOT UP FROM THE TOILET AND TURNED TO FLUSH. DURING THE TURN, HE HAD A SUDDEN ONSET OF BACK AND LEG PAIN. THE PATIENT HAD RETURNED HOME AFTER THE INITIAL SURGERY ON (B)(6) 2018, WITH RESOLUTION OF THE PRE-OP SYMPTOMS. THE PATIENT REPORTED TO CLINIC AFTER THE NEW PAIN AND HAD X-RAY AND COMPUTED TOMOGRAPHY (CT) WHICH SHOWED 5MM SPONDYLOLISTHESIS AS WELL AS THE PLATE AND TWO (2) 6 X 24 SCREWS WHICH HAD PULLED-OUT OF THE S1 VERTEBRAL BODY. THE S1 SCREWS DID NOT BACK OUT FROM THE PLATE. THEY REMAINED LOCKED TO THE PLATE. A POSTERIOR SURGERY WAS PLANNED AND PERFORMED ON (B)(6) 2018. NOTHING WAS EXPLANTED. THE ANTERIOR LUMBAR SPINE WAS NEVER RE-EXPOSED. THE REVISION SURGERY WAS DONE FROM THE POSTERIOR. FROM THE POSTERIOR APPROACH, THE SURGEON ADDED

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 7490827 ↗
• InjuryMay 7, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THE PATIENT UNDERWENT A REVISION ON APRIL 16, 2018 DUE TO BACK AND LEG PAIN, SPONDYLOLISTHESIS, AND A PLATE WITH TWO (2) 6 X 24 SCREWS THAT HAD PULLED-OUT FROM THE S1 VERTEBRAL BODY. THE PATIENT WAS INITIALLY IMPLANTED WITH ONE (1) ANTEGRA-T PLATE, TWO (2) 6.0MM/24MM SCREWS, ONE (1) 6.0MM/26MM SCREW, AND ONE (1) 6.5MM/26MM SCREWS. TWO WEEKS POST-OPERATIVELY FROM AN ANTERIOR LUMBAR INTERBODY FUSION SPINAL (ALIF) AT L5-S1, THE PATIENT GOT UP FROM THE TOILET AND TURNED TO FLUSH. DURING THE TURN, HE HAD A SUDDEN ONSET OF BACK AND LEG PAIN. THE PATIENT HAD RETURNED HOME AFTER THE INITIAL SURGERY ON (B)(6) 2018, WITH RESOLUTION OF THE PRE-OP SYMPTOMS. THE PATIENT REPORTED TO CLINIC AFTER THE NEW PAIN AND HAD X-RAY AND COMPUTED TOMOGRAPHY (CT) WHICH SHOWED 5MM SPONDYLOLISTHESIS AS WELL AS THE PLATE AND TWO (2) 6 X 24 SCREWS WHICH HAD PULLED-OUT OF THE S1 VERTEBRAL BODY. THE S1 SCREWS DID NOT BACK OUT FROM THE PLATE. THEY REMAINED LOCKED TO THE PLATE. A POSTERIOR SURGERY WAS PLANNED AND PERFORMED ON (B)(6) 2018. NOTHING WAS EXPLANTED. THE ANTERIOR LUMBAR SPINE WAS NEVER RE-EXPOSED. THE REVISION SURGERY WAS DONE FROM THE POSTERIOR. FROM THE POSTERIOR APPROACH, THE SURGEON AD

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 7490823 ↗