NA 03.816.012Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034730684), received between May 25, 2018 and May 25, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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.

• InjuryMay 25, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2018, THE DISC ANCHOR BLADE WAS STUCK ON THE ANCHOR BLADE OF AN INSIGHT LATERAL ACCESS RETRACTOR SYSTEM. THE SURGEON ATTEMPTED TO USE A BACK UP INSIGHT LATERAL ACCESS RETRACTOR SYSTEM AND EXPERIENCED THE SAME EVENT WHERE THE DISC ANCHOR BLADE WAS STUCK TO THE ANCHOR BLADE OF THE INSIGHT LATERAL ACCESS RETRACTOR SYSTEM. SINCE THE TWO (2) RETRACTORS FAILED, THE SURGEON WENT WITH A COMPETITOR¿S RETRACTOR. THE PROCEDURE WAS COMPLETED USING THE COMPETITOR¿S RETRACTOR TO ACCESS THE DISC SPACE, BUT THE DEPUY SYNTHES IMPLANTS WERE STILL USED AS AN INTER-BODY. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. AS REPORTED, THE PATIENT HAS BEEN DOING WELL. CONCOMITANT DEVICES REPORTED: KNOB FOR DISC ANCHOR INSTRUMENT (03.816.014, LOT L172936, QUANTITY 1), THIRD BLADE HOLDER (03.816.004, LOT 9275792, QUANTITY 1), THIRD BLADE HOLDER (03.816.004, LOT 9345894, QUANTITY 1) THIS REPORT IS FOR ONE (1) INSTRUMENT FOR DISC ANCHOR THIS IS REPORT 6 OF 6 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7545807 ↗
• InjuryMay 25, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2018, THE DISC ANCHOR BLADE WAS STUCK ON THE ANCHOR BLADE OF AN INSIGHT LATERAL ACCESS RETRACTOR SYSTEM. THE SURGEON ATTEMPTED TO USE A BACK UP INSIGHT LATERAL ACCESS RETRACTOR SYSTEM AND EXPERIENCED THE SAME EVENT WHERE THE DISC ANCHOR BLADE WAS STUCK TO THE ANCHOR BLADE OF THE INSIGHT LATERAL ACCESS RETRACTOR SYSTEM. SINCE THE TWO (2) RETRACTORS FAILED, THE SURGEON WENT WITH A COMPETITOR¿S RETRACTOR. THE PROCEDURE WAS COMPLETED USING THE COMPETITOR¿S RETRACTOR TO ACCESS THE DISC SPACE, BUT THE DEPUY SYNTHES IMPLANTS WERE STILL USED AS AN INTER-BODY. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. AS REPORTED, THE PATIENT HAS BEEN DOING WELL. CONCOMITANT DEVICES REPORTED: KNOB FOR DISC ANCHOR INSTRUMENT (03.816.014, LOT L172936, QUANTITY 1), THIRD BLADE HOLDER (03.816.004, LOT 9275792, QUANTITY 1), THIRD BLADE HOLDER (03.816.004, LOT 9345894, QUANTITY 1) THIS REPORT IS FOR ONE (1) INSTRUMENT FOR DISC ANCHOR THIS IS REPORT 5 OF 6 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7545666 ↗