N/A 8361025Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00721902468810), received between Oct 1, 2018 and Sep 29, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Break

  Information was received from healthcare provider (HCP) via a manufacturer representative regarding a Patient having L2-5 PS removal and replacement Spinal therapy for Adjacent segment disease after posterolateral fixation at L2-5, L5 intervertebral foraminal stenosis. Date of the initial surgery was (b)(6)2016. Procedure/therapy involved in the initial surgery was L2-5 posterolateral fixation and the reason for revision surgery was Adjacent segment disease and intervertebral foraminal stenosis after posterolateral fixation at L2-5. It was reported that the L2-5 PS was planned to be replaced in a total of 8 screws, but due to breakage of the driver tip in this report, and although every possible means was attempted, the existing screws were too firmly fixed, so 3 screws could not be removed and replaced, and the post portion was left in the body. There was no patient symptoms reported. There were no further complications reported regarding the event. Additional information received from the manufacturer representative that there was no malfunction with the screws and It is believed that the cause was that an 8.5 mm diameter screw had been inserted and was fitting very tightly. Addi

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50929801 ↗
• MalfunctionNov 21, 2025No Apparent Adverse Event; No Apparent Adverse Event

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L4/5 PLF. PREOPERATIVE DIAGNOSIS OF THIS SURGERY WAS ADJACENT INTERVERTEBRAL DISORDER. IT WAS REPORTED THAT THE SCREW BECAME STRIPPED AND COULD NOT BE REMOVED; WERE ABLE TO REMOVE THREE OF THE SCREWS WITH A REMOVER SCREWDRIVER, BUT ONE REMAINED IN PLACE. THE 8110530 X10 REMOVER SCREWDRIVER LOCK 3.0MM WAS MISTAKENLY USED. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE 3.2MM DRIVER WAS NOT USED AND IT HAD NO PROBLEMS. THE SCREW REMOVAL DRIVERS GRIP BECAME LOOSE AND IT COULDN'T BE PULLED OUT ALL FOUR SCREWS THAT WERE ORIGINALLY IN IT. THIS SURGERY IS TO REPLACE IT WITH AN IMPLANT MADE BY ANOTHER COMPANY. IT IS NOT A DEFECT OF THE SCREW. AFTER OBTAINING BONE FUSION AFTER L4/5PLF, ADJACENT INTERVERTEBRAL DISORDERS OCCURRED AND REOPERATION WAS REQUIRED. THE SURGEON DOCTOR IS CURRENTLY USING ANOTHER COMPANY'S PRODUCT, AND INSTEAD OF USING A REVISION THAT IS AN EXTENSION OF 3DX, HE PLANNED TO REMOVE ALL 3DX ONCE (L4/5) AND PERFORM A RE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23614812 ↗
• MalfunctionApr 18, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING REVISION SURGERY. IT WAS REPORTED THAT THE TSRH-3D SYSTEM WAS IN PLACE FROM L2 TO S1, AND WHEN ATTEMPTING TO USE THE PRODUCT TO REMOVE THE SCREW FROM THE RIGHT L5, THE HEXAGONAL TIP BROKE. THE HEX DRIVER TIP BROKE AND REMAINED IN THE SCREW POST. IT BROKE OFF RIGHT AT THE EDGE OF THE SCREW POST'S RECEPTACLE, MAKING REMOVAL IMPOSSIBLE. THERE WERE NO PATIENT SYMPTOMS REPORTED. THE INITIAL SURGERY WAS L2-S1 LUMBAR POSTERIOR ANCHORING AND REASON FOR REVISION SURGERY WAS DEFORMATION OF KYPHOSIS BETWEEN PROXIMAL ADJACENT VERTEBRAE. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21863423 ↗
• MalfunctionFeb 23, 2025Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE TIP OF THE SCREWDRIVER BROKE OFF. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21442892 ↗
• MalfunctionFeb 13, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT UNDERGOING SPINAL THER APY FOR L4-5 SPONDYLOSIS. IT WAS REPORTED THAT THE NAV TAP WAS BENT, SCREWDRIVER BROKE AND THE SLEEVE WAS STUCK DURING THE SURGERY. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21372372 ↗
• MalfunctionJun 19, 2024Break; Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED PRIOR TO USE. IT WAS REPORTED THAT TIP IS BROKEN OFF. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19564778 ↗
• MalfunctionMar 15, 2021Break; Break

  INFORMATION RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP FOR A PATIENT UNDERGOING T4-ILIAC POSTERIOR FUSION AND POSTERIOR SUBTRACTION OSTEOTOMY AT T9 AND L3. IT WAS REPORTED THAT, DURING SCREW REMOVAL THE TIP OF THE DRIVER SHEARED OFF. PATIENT HAD BEEN PREVIOUSLY IMPLANTED IN 2015, SO THERE WAS EXCESS BONE FORMATION AROUND SCREW WHICH MADE DIFFICULT TO REMOVE. AFTER DRIVER TIP SHEARED, SURGEON USED A SCREW FRAGMENT TREPHINE AND REVERSE THREAD ¿EASY-OUT¿ DRIVER TO EXPLANT SCREW. THIS WAS A REVISION SURGERY PERFORMED DUE TO FRACTURE AT T9. PATIENT HAD AN INJURY AND IT REQUIRED AN EXTENSION TO THE EXISTING FUSION. A DELAY OF APPROXIMATELY 30-45 MINUTES TO THE PROCEDURE OCCURRED BUT DIDN¿T HAVE A NEGATIVE IMPACT ON PATIENT OR SUCCESS OF PROCEDURE. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11479239 ↗
• MalfunctionDec 27, 2019Break; Break

  IT WAS REPORTED THAT INTRA-OP, WHEN THE SCREWS WERE BEING INSERTED, TIP OF THE SCREWDRIVER BROKE. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9526802 ↗
• MalfunctionDec 27, 2019Break; Break

  IT WAS REPORTED THAT INTRA-OP, WHEN THE SCREWS WERE BEING INSERTED, TIP OF THE SCREWDRIVER BROKE. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9526776 ↗
• MalfunctionOct 1, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH ADJACENT LEVEL DDD ( DEGENERATIVE DISK DISEASE) AND UNDERWENT SURGERY AT L4 LEVEL. DURING THE SURGERY, THE TIP OF THE DRIVER BROKE OFF. THE SCREWDRIVER INTERFACE WITH THE BONE BECAME SO HARD THAT IT STOPPED TURNING AND AS A RESULT THE TIP OF THE SCREW DRIVER BROKE OFF. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO FRAGMENTS OF THE DRIVER WERE REMAINING IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7921636 ↗
• MalfunctionOct 1, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH ADJACENT LEVEL DDD ( DEGENERATIVE DISK DISEASE) AND UNDERWENT SURGERY AT L4 LEVEL. DURING THE SURGERY, THE TIP OF THE DRIVER BROKE OFF. THE SCREW INTERFACE WITH THE BONE BECAME SO HARD THAT IT STOPPED TURNING AND AS A RESULT THE TIP OF THE SCREW DRIVER BROKE OFF. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO FRAGMENTS OF THE DRIVER WERE REMAINING IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7921625 ↗