activL® FW961RRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04038653425587), received between Apr 27, 2021 and Mar 17, 2022 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 17, 2022Entrapment of Device; Compatibility Problem; Entrapment of Device; Compatibility Problem

  IT WAS REPORTED TO AESCULAP AG THAT AN ACTIV L INSERTION INSTRUMENT F/H8.5MM (PART # FW961R) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, A SURGEON'S GLOVE CAUGHT ON THE COMPONENT INTRAOPERATIVELY. THIS OCCURRED DURING USE WITH THE MALLET; THE GLOVE CAUGHT IN THE BLUE-RINGED PORTION OF THE HANDLE (CLOSEST TO THE DOCTOR). FLUOROSCOPY WAS USED AND RESULTS ENSURED THAT THE IMPLANT WAS IN THE CORRECT POSITION. THERE WAS NO BACK UP DEVICE AVAILABLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ADDITIONAL INFORMATION WAS RECEIVED ON FEBRUARY 14, 2022 WHICH REVEALED THE FOLLOWING: THE PIECE OF THE GLOVE FRAGMENT WAS CAUGHT IN THE BLUE RINGED PORTION OF THE DEVICE. THIS BLUE RING PORTION WAS DESCRIBED AS THE COLOR CODED PIECE THAT COVERS THE YELLOW THREADED PORTION OF THE DEVICE. THE SURGEON ONLY HAD ONE ACTIV L INSERTION INSTRUMENT F/H8.5MM, AS SUCH FLUOROSCOPY WAS USED TO ENSURE THE IMPLANT WAS PLACED APPROPRIATELY AS THE INSERTION DEVICE WOULD NOT BE ABLE TO BE USED AGAIN ON THE PATIENT. THE PHYSICIAN CONFIRMED THAT THE IMPLANT WAS IN THE RIGHT PLACE AND THE SURGERY WAS CONTINUED WITHOUT ANY HARM TO THE PATIENT OR SURGICAL DELAYS. AN ADDITIONAL MEDICA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13793110 ↗
• InjuryMar 15, 2022Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED TO AESCULAP INC. THAT A ACTIV L INSERTION INSTRUMENT F/H8.5MM (PART # FW961R) WAS IMPLANTED DURING A PRIMARY PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, DURING THE IMPLANT OF ACTIVL, THE SURGEON'S GLOVE BECAME CAUGHT IN THE ACTIV L INSERTION INSTRUMENT AS HE WAS USING A MALLET TECHNIQUE TO MAKE SURE THE DEVICE WAS PLACED SECURELY. AS HE WAS MALLET-ING THE DEVICE IN PLACE THE GLOVE WAS CAUGHT IN THE BLUE RINGED PORTION OF THE HANDLE (CLOSEST TO THE DOCTOR). AS SUCH THE DOCTOR USED X-RAY, FLUOROSCOPY TO ENSURE THE IMPLANT WAS IN THE CORRECT POSITION. THERE WAS NO BACK UP DEVICE AVAILABLE, BUT THE FLUOROSCOPY FOUND THAT THE DEVICE WAS PLACED IN THE CORRECT LOCATION. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO FURTHER INTRAOPERATIVE EVENTS OR ISSUES. THE SURGEON REPORTED THAT, IN THE FUTURE, HE WILL ALWAYS HAVE TWO OF THESE INSTRUMENTS IN A PROCEDURE IN THE EVENT THAT THIS SHOULD OCCUR AGAIN. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE PATIENT UNDERWENT ADDITIONAL UNEXPECTED DIAGNOSTIC INTERVENTION AS A RESULT OF THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED WHICH REVEALED: THE PIECE OF THE GLOVE FRAGMENT WAS CAUGH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13771040 ↗
• MalfunctionNov 16, 2021Break; Break

  IT WAS REPORTED TO AESCULAP AG THAT AN ACTIV L INSERTION INSTRUMENT F/H8.5MM (PART # FW961R) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, ONE OF THE PINS ON THE ACTIVL INSERTER THAT INTERFACES WITH THE IMPLANT BROKE OFF. THE COMPLAINT DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12822328 ↗
• MalfunctionApr 27, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH FW961R - ACTIV L INSERTION INSTRUMENT F/H8.5MM DURING LUMBAR TDR PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINT DESCRIPTION, THE IMPLANT IS STICKING ON INSERTER. DOCTOR REQUESTED REPLACEMENT. THERE WAS NO SURGERY DELAY AND THE PATIENT WAS UNDER ANESTHESIA. THE SURGEON WAS ABLE TO CONTINUE THE SURGERY WITH THIS INSTRUMENT. IT JUST WASN'T HOLDING AS TIGHT AS IT USED TO, SO THEY WANT TO REPLACE IT. THERE WAS NO PATIENT OR IMPLANT IMPACTED. THERE WAS NO DESCRIBED PATIENT HARM. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE / WAS NOT AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11731436 ↗