ES2 SPINAL SYSTEM 48280185Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327003413), received between Apr 26, 2017 and Apr 26, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Hole In Material” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 26, 2017Hole In Material; Metal Shedding Debris; Residue After Decontamination; Residue After Decontamination

  IT WAS REPORTED THAT THEY ANALYSED WHAT LOOKED LIKE DEBRIS ON KITS THAT HAD BEEN RETURNED FROM AN EXTERNAL STERILISATION PROVIDER AND FOUND BOTH DEBRIS AND RUST. FOLLOWING RE-PROCESSING THE CUSTOMER FOUND DEBRIS ON THE KITS AND AFTER THEY REPEATED THE WASH AND CLEAN PROCESSES WITH ULTRASONIC PRE CLEAN, THE SETS STILL HAVE DEBRIS ON SOME INSTRUMENTS. THE ADVERSE INCIDENT RECORDED BY THE CUSTOMER INTERNALLY STATED THAT 'TRAYS OPENED FOR PATIENTS OPERATION. DEBRIS IN CANNULATED TAPS AND SCREW DRIVER HANDLE, THEREFORE KIT UNUSABLE. SO INSTRUMENT TRAY, TAPS AND AWL HAVE DEBRIS IN. THEN KIT 3 OPENED, DEBRIS IN AWL AND CANNULATED TAPS. NO OTHER KIT AVAILABLE IN HOSPITAL. THE FIXATION TRAY, HOLE IN KIT THROUGH ALL LAYERS AND DEBRIS THEREFORE CASE CANCELLED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6523765 ↗
• MalfunctionApr 26, 2017Hole In Material; Metal Shedding Debris; Residue After Decontamination; Residue After Decontamination

  IT WAS REPORTED THAT THEY ANALYSED WHAT LOOKED LIKE DEBRIS ON KITS THAT HAD BEEN RETURNED FROM AN EXTERNAL STERILISATION PROVIDER AND FOUND BOTH DEBRIS AND RUST. FOLLOWING RE-PROCESSING THE CUSTOMER FOUND DEBRIS ON THE KITS AND AFTER THEY REPEATED THE WASH AND CLEAN PROCESSES WITH ULTRASONIC PRE CLEAN, THE SETS STILL HAVE DEBRIS ON SOME INSTRUMENTS. THE ADVERSE INCIDENT RECORDED BY THE CUSTOMER INTERNALLY STATED THAT 'TRAYS OPENED FOR PATIENTS OPERATION. DEBRIS IN CANNULATED TAPS AND SCREW DRIVER HANDLE, THEREFORE KIT UNUSABLE. SO INSTRUMENT TRAY, TAPS AND AWL HAVE DEBRIS IN. THEN KIT 3 OPENED, DEBRIS IN AWL AND CANNULATED TAPS. NO OTHER KIT AVAILABLE IN HOSPITAL. THE FIXATION TRAY, HOLE IN KIT THROUGH ALL LAYERS AND DEBRIS THEREFORE CASE CANCELLED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6523763 ↗