n/a X1119042Recalls & reported problems
Medtronic Sofamor Danek, Inc. · REDUCER X1119042 SEQUENTIAL ROD · Class 1
Data updated Oct 16, 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 00763000369729), received between Jun 22, 2022 and Mar 25, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Failure to Align” (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.
Reports received per month
Most reported problems
Device problems
- Failure to Align1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Unspecified Nervous System Problem1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 25, 2025Material Twisted/Bent; Material Twisted/Bent
INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING INSTRUMENTS TO BE USED IN UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT ONE RATCHET HANDLE WILL NOT RATCHET, TWO RATCHET HANDLES AND SCREWDRIVER WERE STRIPPED, AND REDUCER TIP WAS BENT. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21685590 ↗InjuryJun 22, 2022Failure to Align; Failure to Align
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT IT DID SEEM TO BE A STRUGGLE FROM THE BEGINNING OF THE CASE TO GET THE REDUCERS TO SEED CORRECTLY TO THE HEADS OF THE SCREW. AS THE DR WAS TWISTING THE REDUCER TO REDUCE THE ROD, THE INSTRUMENT POPPED OF THE HEAD OF THE SCREW AND MOVED MEDIALLY AND HIT THE EXPOSED SPINAL CORD IN A POSTERIOR CERVICAL THE PATIENT MOTORS DECREASED. THERE WERE NO VISIBLE TEARS BUT THE PATIENT HAD SIGNIFICANT DROP OF 85%. DR. PATEL AND ANESTHESIA TEAM STARTED SPINAL CORD INJURY TREATMENT. SLOW IMPROVEMENTS WERE SEEN AND WHEN THE PATIENT WAS EXTUBATED HE WAS FOLLOWING MINIMAL COMMANDS AND COULD MOVE HIS ARMS AND HAND. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: Unspecified Nervous System Problem
MAUDE report 14768356 ↗
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- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
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- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 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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