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ENDOSKELETON® TAS 2300-6530Recalls & reported problems

Medtronic Sofamor Danek, Inc. · Bone Screw, 6.5mm x 30mm · Class 2 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00191375001874), received between Feb 22, 2018 and Jan 11, 2019 — classified as 1 injury, 1 malfunction.

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 18, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Break1

Patient problems

  • No Consequences Or Impact To Patient1
  • Pain1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryJan 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE SURGEON WAS IMPLANTING THE SCREW AND FELT THE LENGTH WAS TOO LONG, SO THEY DECIDED TO UTILIZE A SMALLER SCREW SIZE. UPON REMOVAL OF THE INITIAL SCREW, THEY NOTICED THE SCREW THREADING WAS STRIPPED IN PLACES.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8241863 ↗
  • MalfunctionFeb 22, 2018Break; Break

    IT WAS REPORTED THAT, POST-OPERATIVELY, A BONE SCREW FRACTURED INSIDE A PATIENT. THE ORIGINAL L4-L5 SURGERY WAS PERFORMED ON (B)(6) 2017, AND THE REPORTED ISSUE OCCURRED APPROXIMATELY 6-7 WEEKS AFTER THE SURGERY. AN EXACT INCIDENT DATE WAS NOT PROVIDED. THE PATIENT, WHO THE SURGEON DESCRIBED AS HAVING "GOOD BONE QUALITY," WAS REPORTEDLY DOING WELL 4 WEEKS AFTER THE SURGERY. AFTER ABOUT 6 WEEKS, THE PATIENT STARTED TO PRESENT ACUTE BACK PAIN. X-RAYS WERE TAKEN TO DISCOVER A BROKEN SCREW. THE PATIENT WAS PUT UNDER LUMBAR BONE STIMULATION, AND THE SURGEON STATED THAT HE THOUGHT "THE PATIENT WOULD BE FINE AS LONG AS NO OTHER SLIP OR CAGE DISPLACEMENT OCCURRED." IT WAS STATED THAT THERE HAD BEEN NO REVISION SURGERY FOR SUPPLEMENTAL FIXATION AND THE SCREW REMAINED INSIDE THE PATIENT.

    Patient problems: Pain

    MAUDE report 7290736 ↗

Other Intervertebral fusion device with integrated fixation, lumbar devices

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Sources and updates

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