N/A 5584332Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169086159), received between Dec 3, 2021 and Oct 16, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (1 report).

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

• MalfunctionOct 16, 2025Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING REOPERATION FOR ADOLESCENT IDIOPATHIC SCOLIOSIS (AIS) INVOLVING LEVELS TH2-L3 . IT WAS REPORTED THAT THETIP OF THE DRIVER WAS DAMAGED DURING TRANSLACE REMOVAL. 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 23307926 ↗
• MalfunctionDec 3, 2021Failure to Align; Mechanics Altered; Failure to Align; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH SYMPTOMS OF OYL (OSSIFICATION OF YELLOW LIGAMENT) INVOLVED IN CRIMPING THE SCREW STRONGER THAN USUAL. LEVELS IMPLANTED - T2-5. IT WAS REPORTED THAT INTRA-OPERATIVELY, THOUGH THE SCREW WAS ATTACHED TO THE SCREWDRIVER, THERE WAS TOO MUCH LOOSENESS AT THE TIP, AND IT COULD NOT BE ATTACHED SQUARELY. PRODUCT WAS USED CORRECTLY ACCORDING TO THE DIRECTIONS GIVEN IN THE IFU/LABELING. EVENT WAS ASSOCIATED WITH THE PATIENT. ADDITIONAL TREATMENT/SURGERY PERFORMED TO REINSERT THE SCREW. THERE WAS DELAY IN OVERALL PROCEDURE TIME FOR LESS THAN 60 MINUTES. NO HEALTH DAMAGE IN THE PATIENT WAS REPORTED. ON 2021-MAY-11, RECEIVED ADDITIONAL INFORMATION THAT S5 (RMAS) WAS USED FOR UPPER THORACIC SPINE FIXATION. EVEN THOUGH THE TIP WAS ALIGNED WHEN CONNECTING THE SCREW TO THE CNRMAS LS SCREWDRIVER (5584332), THERE IS A LOT OF LOOSENESS, AND IT WAS DIFFICULT TO ATTACH IT STRAIGHT. SINCE THERE WAS A LOT OF LOOSENESS FROM THE BEGINNING, EVEN THOUGH THE SLEEVE WAS SQUEEZED TIGHTLY WITH CLEANING RAGS AND WAS CRIMPED, IT WAS DIFFICULT TO TURN THE SLEEVE AND ATTACH IT STRAIGHT. WHEN THE RMAS SCREW WAS ATTACHE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12922569 ↗