N/A 7578900Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00613994644831), received between Apr 24, 2020 and Feb 10, 2025 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 10, 2025Break; Break

  INFORMATION RECEIVED FROM USER FACILITY VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING POST-OP OF THE REPORTED PRODUCT. IT WAS REPORTED THAT, THE INSTRUMENT SCREWDRIVER WAS BROKEN. THERE WAS NO PATIENT INVOLVED DURING THIS EVENT. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21342381 ↗
• MalfunctionJul 1, 2024Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A SETSCREW DRIVER USED ON THE PATIENT HAVING T10-L4 SPINAL FUSION FOR CHANCE FRACTURE. IT WAS REPORTED THAT THE INSTRUMENT WAS BROKEN. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED THAT WHEN THE LATCH WAS PRESSED, THE ROD GRIP DOES NOT OPEN. THERE WAS DAMAGE TO THE OPENING AND CLOSING MECHANISM. PRODUCT CAME IN CONTACT WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19642486 ↗
• InjuryMay 18, 2021Mechanical Jam; Mechanical Jam

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP FOR A PATIENT UNDERGOING A PROCEDURE OF CORRECTION FIXATION WITH TRAUMA DEVICE FOR L1 FRACTURE. THE PRE-OP DIAGNOSIS WAS L1 BURST - FRACTURE. IT WAS REPORTED THAT, ON ONE DRIVER, THE BUTTON FOR LOCKING THE SET SCREW ON THE UPPER PART OF DRIVER HANDLE WAS STUCK IN AND THE SET SCREW DID NOT COME OFF AT ALL. THE SET SCREW GOT CAUGHT IN THE RETAINING SET SCREWDRIVER AND COULD NOT BE REMOVED. THE OPERATION OF ANOTHER ONE DRIVER WAS SUSPICIOUS, AND SOMETIMES THE BUTTON COULD BE PRESSED AND SOMETIMES COULD NOT BE PRESSED. THE BUTTON THAT WAS PRESSED DID NOT RETURN, AND THE LOCK THAT GRIPS THE SET SCREW COULD NOT BE RELEASED. THE EXTENDER HAD AN ISSUE, WHEN ATTEMPTING TO PLACE ROD AFTER CORRECTION WITH TRAUMA DEVICE, IT WAS NOTICED THAT THE EXTENDER HAD COME OFF AND THE CORRECTION EFFECT WAS LOST. THE REPORTED SCREW ON THE RIGHT SIDE OF TH12 SEEMED TO HAVE MOVED TO THE CRANIAL SIDE FROM THE INITIAL PLACEMENT, THE SCREW MIGHT BE LOOSENED. IT WAS MENTIONED THAT, THE PLANNED CORRECTION WAS NOT COMPLETED. ALL THE REPORTED PRODUCTS WERE USED ACCORDING TO THE IFU/LABELLIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11841159 ↗
• InjuryNov 2, 2020Mechanical Jam; Mechanical Jam

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A FIELD CONTACT REGARDING A PATIENT WITH A PRE-OPERATIVE DIAGNOSIS OF COMPRESSION FRACTURE AT L1, UNDERGOING A POSTERIOR SPINAL FIXATION BY PPS OF T11, T12, L2 AND L3. IT WAS REPORTED THAT THE BUTTON ON THE UPPER PART OF HANDLE OF THE SET SCREW DRIVER WAS TOO HARD TO BE PRESSED. ONE OF THE TWO PRODUCTS COULDN'T BE USED AT ALL, AND THE OTHER ONE WAS ALSO HARD, BUT IT WAS MANAGED TO USE IT TO THE END. PPS WAS INSERTED FROM T11 TO L3, AND SAS WAS USED FOR TH12. AFTER THE FINAL TIGHTENING OF PS AT L2 AND L3 WAS PERFORMED, DISTRACTION WAS PERFORMED WITH TRA UMA DEVICE, AND KYPHOSIS CORRECTION WAS PERFORMED. THERE WAS A DELAY OF OVER 60 MINUTES. THERE WERE NO PATIENT SYMPTOMS/COMPLICATIONS AS A RESULT OF THIS EVENT. THE OPERATION OF BUTTON OF THE REPORTED DRIVER WAS NOT SMOOTH, IT COULD NOT BE PRESSED AT ALL, OR EVEN THOUGH THE BUTTON COULD BE PRESSED, IT DID NOT RETURN. IT HAD NOT BEEN CONFIRMED WHETHER IT WAS A SPRING PROBLEM OR A SHAFT DEFORMATION. THE REPORTED PRODUCT WAS CONSIGNMENT, BUT IT HAD NOT BEEN USED FOR A WHILE. INITIAL REPORTER INFORMATION AND PATIENT INFORMATION CANNOT BE PROVIDED DUE TO THE RESTRICTION BY THE PR

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10768525 ↗
• InjuryNov 2, 2020Mechanical Jam; Mechanical Jam

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A FIELD CONTACT REGARDING A PATIENT WITH A PRE-OPERATIVE DIAGNOSIS OF COMPRESSION FRACTURE AT L1, UNDERGOING A POSTERIOR SPINAL FIXATION BY PPS OF T11, T12, L2 AND L3. IT WAS REPORTED THAT THE BUTTON ON THE UPPER PART OF HANDLE OF THE SET SCREW DRIVER WAS TOO HARD TO BE PRESSED. ONE OF THE TWO PRODUCTS COULDN'T BE USED AT ALL, AND THE OTHER ONE WAS ALSO HARD, BUT IT WAS MANAGED TO USE IT TO THE END. PPS WAS INSERTED FROM T11 TO L3, AND SAS WAS USED FOR TH12. AFTER THE FINAL TIGHTENING OF PS AT L2 AND L3 WAS PERFORMED, DISTRACTION WAS PERFORMED WITH TRA UMA DEVICE, AND KYPHOSIS CORRECTION WAS PERFORMED. THERE WAS A DELAY OF OVER 60 MINUTES. THERE WERE NO PATIENT SYMPTOMS/COMPLICATIONS AS A RESULT OF THIS EVENT. THE OPERATION OF BUTTON OF THE REPORTED DRIVER WAS NOT SMOOTH, IT COULD NOT BE PRESSED AT ALL, OR EVEN THOUGH THE BUTTON COULD BE PRESSED, IT DID NOT RETURN. IT HAD NOT BEEN CONFIRMED WHETHER IT WAS A SPRING PROBLEM OR A SHAFT DEFORMATION. THE REPORTED PRODUCT WAS CONSIGNMENT, BUT IT HAD NOT BEEN USED FOR A WHILE. INITIAL REPORTER INFORMATION AND PATIENT INFORMATION CANNOT BE PROVIDED DUE TO THE RESTRICTION BY THE PR

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10768521 ↗
• MalfunctionApr 24, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH DEGENERATIVE DISC DISEASE; AND UNDERWENT MINIMALLY INVASIVE SURGERY - FIXATION AT L5-S1. INTRA-OP, THE INNER SHAFT OF SET SCREW DRIVER WAS BENT AND THE BUTTON ON TOP WILL NOT RELEASE SET SCREW EASILY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9994561 ↗