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CRESCENT™ Spinal System X0912057Recalls & reported problems

Medtronic Sofamor Danek, Inc. · INSERTER X0912057 SHORT THREADED SHAFT · Class 2

All models of CRESCENT Spinal System (18)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169306370), received between Aug 13, 2018 and Oct 4, 2018 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Break3

Patient problems

  • Device Embedded In Tissue or Plaque3
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjuryOct 4, 2018Break; Break

    IT WAS REPORTED THAT THE PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION AT T10-ILLIAC. DURING SURGERY, THE TIP OF THE INSERTER BROKE AND WAS STUCK INSIDE THE CAGE. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. FRAGMENTS OF THE BROKEN PART REMAINED INSIDE THE PATIENT. NO PATIENT SYMPTOMS OR COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT.

    Patient problems: Device Embedded In Tissue or Plaque

    MAUDE report 7936797 ↗
  • InjuryAug 17, 2018Break; Break

    IT WAS REPORTED THAT THE PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L4-S1. DURING SURGERY, THE TIP OF THE INSERTER WAS BROKEN AND WAS STILL INSIDE THE CAGE. FRAGMENTS OF THE BROKEN PART REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

    Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

    MAUDE report 7792539 ↗
  • InjuryAug 13, 2018Break; Break

    IT WAS REPORTED THAT THE PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) SURGERY AT L4-S1 LEVELS. DURING SURGERY, THE TIP OF INSERTER WAS BROKEN. THE BROKEN TIP OF THE INSERTER REMAINED IN THE PATIENT. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Patient problems: Device Embedded In Tissue or Plaque

    MAUDE report 7777075 ↗

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Sources and updates

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