activL® FW965RRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04038653431441), received between Jul 14, 2020 and Feb 15, 2022 — classified as 2 malfunctions.

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

• MalfunctionFeb 15, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED TO AESCULAP AG THAT AN ACTIV L REVISION DISTRACT.FORCEPS ANGLED (PART # FW965R) WAS USED DURING A L4-5 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) TOTAL DISC REPLACEMENT (TDR) PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE PRONGS WERE BENT DURING REPOSITIONING. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. A SURGICAL DELAY OF APPROXIMATELY TEN (10) MINUTES WAS REPORTED. THE PATIENT OUTCOME WAS NOTED AS BEING "GREAT". THE MALFUNCTION WAS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13535810 ↗
• MalfunctionJul 14, 2020Material Fragmentation; Material Deformation; Material Fragmentation; Material Deformation

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE PRODUCT ACTIV L REVISION DISTRACT FORCEPS ANGLED. SPECIFICALLY, IT WAS REPORTED THAT THE SURGEON PLACED THE DISTRACTOR INTO THE IMPLANT IN AN ATTEMPT TO OPEN THE IMPLANT TO RETRIEVE THE POLY INSERT. UPON FULL DISTRACTION, THE TIP OF THE DISTRACTOR BENT AND THE INSTRUMENT COULD NOT BE USED AS INTENDED. THE SCRUB TECHNICIAN ATTEMPTED TO STRAIGHTEN THE BENT TIP AT WHICH POINT THE TIP BROKE AWAY FROM THE INSTRUMENT. THE SURGEON USED A NUVASIVE PADDLE DISTRACTOR TO OPEN THE DISC SPACE. THE BROKEN TIP WAS NEVER INSIDE THE WOUND AND WAS THEN THROWN AWAY. THERE WAS NO PATIENT HARM. THIS MALFUNCTION PROLONGED THE SURGERY FOR 20 MINUTES. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED AS OF THE DATE OF THIS REPORT. THE MALFUNCTION IS FILED UNDER AAG REFERENCE XC (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10271556 ↗