NA 03.620.022Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034717616), received between Jun 30, 2017 and Jun 3, 2022 — classified as 3 injuries.

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

• InjuryJun 3, 2022Break; Material Integrity Problem; Break; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A LUMBAR SPONDYLOSIS STENOSIS, RADICULOPATHY, XL1F L3-4, OPEN POSTERIOR REVISION WITH L3-5 DECOMPRESSION POSTERIOR LATERAL FUSION INSTRUMENTATION, L3-S1, SCREWS, RODS, ALLOGRAFT. THIS REVISION WAS RELATED TO THE PREVIOUS SURGERY IN WHICH, A SCREWDRIVER WAS BROKEN AND LACERATED PATIENT'S ILIAC ARTERY. THIS EVENT IS CAPTURED IN RELATED COMPLAINT (B)(4). THIS REPORT IS FOR A SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Perforation of Vessels

  MAUDE report 14598196 ↗
• InjuryAug 8, 2019Break; Break

  IT WAS REPORTED THAT ON OR ABOUT (B)(6) 2017, THE PATIENT UNDERWENT A PROCEDURE TO TREAT A DEGENERATIVE LUMBAR DISC DISEASE, L5-S1, L4-5, HERNIATED DISC L5-S1 AND L4-5, POST-LAMINECTOMY SYNDROME, L5-S1, CHRONIC BACK PAIN AND BILATERAL LUMBAR RADICULOPATHY ACQUIRED FROM A PREVIOUS LAMINECTOMY PROCEDURE. A T25 STARDRIVE SCREWDRIVER SHAFT WAS USED TO INSTALL A SCREW IN THE PATIENT'S BACK. DURING THIS PROCEDURE, THE SCREWDRIVER BROKE, RESULTING IN A LACERATION OF THE LEFT ILIAC VEIN AND SUBSEQUENT THROMBOSIS OF THE LEFT ILIAC ARTERY. AT THE END OF THE PROCEDURE, THE PATIENT WAS STABLE BUT AS A RESULT OF THE LACERATION, SUFFERED PALSY INJURIES INCLUDING NERVE INJURIES TO THE ARMS, LEGS, AND BACK, DISABILITY, AND PAIN. CONCOMITANT DEVICES: SCREW (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: UNKNOWN). THIS REPORT IS FOR A STARDRIVE SCREWDRIVER SHAFT.

  Patient problems: Nerve Damage; No Code Available; Pain

  MAUDE report 8876350 ↗
• InjuryJun 30, 2017Break; Material Fragmentation; Break; Material Fragmentation

  CLARIFICATION OF EVENTS WAS RECEIVED FROM THE SURGEON ON SEPTEMBER 25, 2017. THE SURGEON STATED THAT THE PATIENT UNDERWENT AN ALIF AT L5-S1 AND WAS IMPLANTED WITH A 13MM MUSCULOSKELETAL TRANSPLANT FOUNDATION (MTF) LUMINARY SPACER WHICH WAS PLACED IN THE L5-S1 DISC SPACE AS A STRUCTURAL BONE GRAFT. THE PATIENT WAS ALSO IMPLANTED WITH A 43MM ANTEGRA-T PLATE AND FOUR (4), 6.5MM CANCELLOUS LOCKING SCREWS AROUND THE L5-S1 DISC SPACE. THE SURGEON REPORTED THAT HE ATTACHED THE SCREW- ON DRILL GUIDES TO THE ANTEGRA-T PLATE AND USED A CAPTURED AWL TO CREATE THE PILOT HOLES FOR SCREW INSERTION. THE SURGEON PLACED ALL FOUR (4) SCREWS IN THE PLATE AND ADVANCED THEM JUST SHORT OF FINAL TIGHTENING TO ¿DISPERSE THE FORCES¿ TO ALL FOUR (4) SCREWS. A 7NM TORQUE LIMITING HANDLE WAS THEN USED WITH THE T25 STAR DRIVE SCREWDRIVER TO TIGHTEN THE SCREWS. THE SURGEON REPORTED THAT DURING THE SURGERY, THE LEFT L-5 SCREW WAS PROUD AND DID NOT SEAT WITH THE 7NM TORQUE LIMITING SCREWDRIVER. THE OTHER THREE (3) SCREWS WERE REPORTED TO HAVE BEEN SEATED. PER THE SURGEON, HE CHECKED THE THREE (3) SEATED SCREWS FIRST WITH A NON-TORQUE LIMITING SCREWDRIVER AND PLANNED TO TIGHTEN THE SCREW SITTING PROUD LAST TO REDU

  Patient problems: Device Embedded In Tissue or Plaque; No Code Available; Sedation

  MAUDE report 6681768 ↗