NA 03.816.320Recalls & reported problems
Synthes GmbH · DISC ANCHOR BLADE 120MM FOR 3RD BLADE HOLDER · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034731025), received between Apr 25, 2018 and Apr 25, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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
Device problems
- Device Operates Differently Than Expected1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
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 2 OF 4 FOR (B)(4).
Patient problems: No Code Available
MAUDE report 7463011 ↗
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- Omni-Tract® 3104RIntegra Lifesciences Corporation · RETRACTOR1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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