NA 03.816.330Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034731032), received between Apr 25, 2018 and Jul 15, 2021 — classified as 1 injury, 1 malfunction.

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

• MalfunctionJul 15, 2021Compatibility Problem; Compatibility Problem

  IT WAS FURTHER REPORTED THAT THE SHIM THAT DEPLOYS FROM THE POSTERIOR BLADE COULD NOT BE RETRACTED. IT ¿JAMMED¿/BECAME LOCKED ONCE IN IT¿S DEPLOYED STATE. THEREFORE, AT THE END OF THE PROCEDURE THE DOCTOR HAD A VERY DIFFICULT TIME REMOVING THE RETRACTOR BECAUSE THE SHIM WAS STILL DEPLOYED IN THE DISC SPACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12176898 ↗
• InjuryApr 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: BUTTON FOR DISC ANCHOR INSTRUMENT (PART 03.816.015, LOT UNKNOWN, QUANTITY 1), INSTRUMENT FOR DISC ANCHOR (PART 03.816.012, LOT UNKNOWN, QUANTITY 1), KNOB FOR DISC ANCHOR INSTRUMENT (PART 03.816.014, LOT UNKNOWN, QUANTITY 1), THIRD (3RD) BLADE HOLDER (PART 03.816.004, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) DISC ANCHOR BLADE FOR 3RD BLADE HOLDER THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7462907 ↗