N/A 7480147Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00721902857089), received between Jan 12, 2021 and Jul 14, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Break” (13 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25810812 ↗
• MalfunctionNov 6, 2024Break; Naturally Worn; Break; Naturally Worn

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (QUALITY INSPECTOR) REGARDING A PART USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE TIP WAS BROKEN AND INSTRUMENT WAS WORN. THERE WAS NO FURTHER INFORMATION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20619744 ↗
• MalfunctionNov 6, 2024Break; Naturally Worn; Break; Naturally Worn

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (QUALITY INSPECTOR) REGARDING A PART USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE TIP WAS BROKEN AND INSTRUMENT WAS WORN. THERE WAS NO FURTHER INFORMATION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20619696 ↗
• MalfunctionNov 6, 2024Break; Naturally Worn; Break; Naturally Worn

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (QUALITY INSPECTOR) REGARDING A PART USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE TIP WAS BROKEN AND INSTRUMENT WAS WORN. THERE WAS NO FURTHER INFORMATION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20619691 ↗
• MalfunctionSep 16, 2024Break; Material Deformation; Material Twisted/Bent; Break; Material Deformation; Material Twisted/Bent

  ADDITIONAL INFORMATION RECEIVED THAT PRODUCT WAS STRIPPED AND WAS USED IN PRIOR/ PREVIOUS PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20229511 ↗
• MalfunctionJun 20, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A L3-L5 MAST TLIF REVISION PROCEDURE IN A PATIENT. IT WAS REPORTED THAT THE FLEX ARM WAS NOT FULLY LOCKING AND WAS LOOSE WHEN FULLY TIGHTENED. THE RATCHETING HANDLE WAS SKIPPING. THE DISTAL END OF THE T27 DRIVER BROKE OFF IN THE SET SCREW. THE BROKEN TIP WAS REMOVED WITH SUCTION. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19573213 ↗
• MalfunctionMay 15, 2024Break; Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A T27 DRIVER USED FOR SPINAL THERAPY. IT WAS REPORTED THAT DRIVER WAS STRIPPED. EVENT OCCURRED DURING ROUTINE INSTRUMENT CHECK. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED THAT INSTRUMENT WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19318633 ↗
• MalfunctionJul 30, 2022Break; Break

  INFORMATION RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP OF THE REP ORTED PRODUCT. IT WAS REPORTED THAT, THE S2 SET SCREW HAD COME OFF FOR THE PATIENT WHO HAS BEEN FIXATED WITH V5 ON TH9-S2, SO REOPERATION FOR THE REATTACHMENT OF THE SET SCREW WAS PERFORMED. LOOSENING WAS ALSO OBSERVED IN THE S1 AND L5 LEFT SET SCREWS, SO THEY WERE REPLACED WITH NEW SET SCREWS AFTER REMOVAL WITH THE SHAFT T27 DRIVER. DURING INTRA-OPERATIVELY, T27 SHAFT BROKE WHEN REMOVING THE SET SCREW ON THE LEFT SIDE OF L5. THE LEVELS IMPLANTED WERE L5 LEFT, S1, S2. THE LOOSENING OF L5 LEFT AND S1 SCREWS WERE OBSERVED DURING REVISION SURGERY INTRA-OPERATIVELY. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15136707 ↗
• MalfunctionMay 30, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR A PREVIOUS LEFT SI FUSION. IT WAS REPORTED THAT, THE DRIVER WAS BROKEN WHILE THE SURGEON PERFORMING REVISION FOR PREVIOUS LEFT SI FUSION. THE SURGEON REMOVED AND REPOSITIONED 3 X RIALTO SCREWS. THE SCREWDRIVER BROKE WHILE TRYING TO REMOVE THE RIALTO SCREWS. THE TIP OF DRIVER WAS BROKEN AND NO BROKEN PIECES WERE LEFT IN THE PATIENT. THERE IS NO ALLEGATION AGAINST THE PREVIOUSLY IMPLANTED SCREWS. THERE WAS NO TIME DELAY IN PROCEDURE REPORTED AS A RESULT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14539598 ↗
• MalfunctionDec 20, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH SYMPTOMS DEGENERATIVE DISC DISEASE (DDD) INVOLVED IN THE OPEN TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) PROCEDURE. IT WAS REPORTED THAT INTRA-OPERATIVELY, INSTRUMENTS BROKE, AND NO FRAGMENTS LEFT IN THE PATIENT'S BODY. PRODUCT WAS UTILIZED CORRECTLY ACCORDING TO THE DIRECTIONS GIVEN IN THE IFU/LABELING. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. PATIENT IS ALIVE AND NO INJURY. ON (B)(6) 2021, RECEIVED ADDITIONAL INFORMATION THAT ALL REPORTED PRODUCTS BROKE INTO TWO OR MORE PIECES. ALL INSTRUMENTS BROKE WHILE PLACING OR REMOVING A SCREW. LEVELS TREATED- S1.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13042005 ↗
• MalfunctionMay 20, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH SYMPTOMS OF LUMBAR DISC HERNIATION INVOLVED IN POSTERIOR LUMBAR SCREW FIXATION PROCEDURE. IT WAS REPORTED THAT AT INTRA-OP, THE SCREWDRIVER BROKE IN THE SCREW PLUG WHEN TIGHTENING. PRODUCT WAS NOT IMPLANTED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THERE WAS NO ADDITIONAL TREATMENT OR SURGERY PERFORMED AS A RESULT OF THIS EVENT. PATIENT IS ALIVE AND NO INJURY. ON 2021-APR-27, RECEIVED ADDITIONAL INFORMATION THAT SCREWDRIVER BROKE IN THE SCREW PLUG AND NO FRAGMENT LEFT IN THE PATIENT'S BODY. DAMAGED SCREW WAS NOT IMPLANTED, AND IT WAS REPLACED. THERE WAS DELAY IN OVERALL PROCEDURE TIME FOR 10 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11854538 ↗
• MalfunctionFeb 3, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH LUMBAR DISC HERNIATION INVOLVED IN POSTERIOR THORACOLUMBAR SURGERY/ INTERNAL FIXATION WITH SCREW ROD PROCEDURE. IT WAS REPORTED THAT AT INTRA-OP, WHEN TO BROKE THE SET SCREW TAIL, THE TOOL WAS BROKEN IN THE SET SCREW. AFTER REPLACING THE SET SCREW WITH A NEW ONE, IT WAS USED NORMALLY. THERE WAS NO FRAGMENTS LEFT IN THE PATIENT'S BODY. PRODUCT WAS NEVER IMPLANTED, REPLACED WITH MEDTRONIC PRODUCT. EVENT WAS ASSOCIATED WITH THE PATIENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THE EVENT. THERE WAS NO ADDITIONAL SURGERY/TREATMENT PERFORMED AS A RESULT OF THE EVENT. PATIENT IS ALIVE AND NO INJURY. ON 2021-JAN-19, RECEIVED ADDITIONAL INFORMATION THAT EVENT OCCURRED DURING IMPLANTATION OF SCREW IN THE PATIENT. TOOL/DRIVER WAS REPLACED WITH ANOTHER ONE DURING THE PROCEDURE. ON 2021-JAN-28, RECEIVED ADDITIONAL INFORMATION THAT DRIVER WAS DISCARDED AFTER SURGERY. SET SCREW DID NOT BREAK. SETSCREW WAS UNUSABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11272452 ↗
• MalfunctionJan 12, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH UNKNOWN INDICATION INVOLVED IN POSTERIOR THORACOLUMBAR SURGERY. IT WAS REPORTED THAT DURING PROCEDURE, WHEN THE SCREW PLUG WAS TIGHTENED, THE TIP OF THE TOOL DRIVER WAS BROKEN IN THE SCREW PLUG, MAKING THE SCREW PLUG UNUSABLE. IN THE PROCESS OF LOCKING THE CROSSLINK, THE SCREW PLUG WAS TIGHTENED, AND THE SCREW PLUG WAS SLIPPED. AS A RESULT, CROSSLINK COULD NOT BE LOCKED AND IT COULD NOT BE INSTALLED. REPORTED SET SCREW WAS NOT IMPLANTED. NO FRAGMENTS LEFT IN THE PATIENT'S BODY. EVENT WAS ASSOCIATED WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11153874 ↗