N/A 9197006Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994120649), received between Dec 3, 2020 and May 5, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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. 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.

• MalfunctionMay 5, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH A SPINAL PRODUCT TYPE FOR OLIF/PSF L5-S1. IT WAS REPORTED THAT WHEN USING THE SLAP HAMMER ON THE BACK OF THE HANDLE, THE SMALL PIECE THAT HOLDS THE SLAP HAMMER TO THE HANDLE BROKE OFF DURING THE CASE. THERE IS A SMALL INNER PIECE AT THE TIP OF THE SET SCREW DRIVER WHICH BROKE DURING THE CASE. THE SCREW DRIVER WILL NOT RETAIN A SET SCREW. OTHER SET SCREWDRIVER WAS USED FOR THE REST OF THE CASE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THERE WAS NO DELAY IN OVERALL PROCEDURE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11775693 ↗
• MalfunctionDec 3, 2020Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH UNKNOWN INDICATION FOR TLIF (TRANSFORAMINAL LUMBAR INTERBODY FUSION)(LEVELS IMPLANTED L3-S1) .IT WAS REPORTED THAT THE INSTRUMENT BROKE. THE PRODUCT WILL BE RETURNED AND REPLACED. NO FURTHER COMPLICATIONS WERE REPORTED. ON (B)(6) 2020, UPDATE RECEIVED FROM REP THE PRODUCT CAME IN PATIENT CONTACT. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10940316 ↗