Medtronic Reusable Instruments 9391300Recalls & reported problems
Medtronic Sofamor Danek, Inc. · ADJUSTER 9391300 IN SITU · Class 2
All models of Medtronic Reusable Instruments (36)
Data updated Oct 18, 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 00613994683717), received between Mar 25, 2021 and Mar 25, 2021 — classified as 1 injury.
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
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURING REPRESENTATIVE REGARDING PATIENT WITH L3/4 VERTEBRAL BODY COLLAPSE SUGGESTED FOR SPINAL THERAPY. POSTERIOR FIXATION WAS PERFORMED AT L1-S2. LEVELS IMPLANTED WAS L3- 4. EVENT OCCURRED INTRA-OP. IT WAS REPORTED THAT L3/4 VERTEBRAL SUBTOTAL REMOVAL WAS PERFORMED AND THE REPORTED IMPLANTS WERE PLACED. THE CAGE WAS LENGTHENED AFTER BEING INSERTED BETWEEN THE VERTEBRAL BODIES, BUT IT SHRANK BEFORE IT WAS FULLY LENGTHENED. WHEN THE CAGE WAS CHECKED OUTSIDE THE OPERATIVE FIELD, IT COULD BE LENGTHENED TO THE END WITHOUT ANY PROBLEM, BUT THE SAME EVENT WAS CONFIRMED IN THE OPERATIVE FIELD. IT WAS ATTEMPTED TO LENGTHEN THE CAGE BY INSERTING AN ADJUSTER INTO THE OPENING FOR FILLING BONE GRAFT, BUT THE CAGE COULDN'T BE LENGTHENED UNTIL THE END. THEREFORE, THE CAGE WAS REPLACED WITH ANOTHER ONE WITH ONE INCREASED SIZE. THE TORQUE LIMITING DRIVER WAS NOT USED. DELAY OF OVER 60 MINUTES WAS REPORTED. IMPLANT WAS EXPLANTED AND BEING RETURNED. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WAS REPORTED. NO DEFECT WAS FOUND IN INSERTER IN APPEARANCE. LOT#CA12G066 AND CA12J027 OF PINION DRIVER HAD SCRATCHES AT TIP. CA13F029-B HAD SCR
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11567365 ↗
Other SPINAL VERTEBRAL BODY REPLACEMENT DEVICE devices
- GIZA Corpectomy implant Giza, Diam 14 mm, 23-32 mm, 7-10 DegEden Spine Europe SA · Spinal Vertebral Body Replacement Device1 recall0 reports
- X-CORE 7160012Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- X-CORE 7220018Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- X-CORE 7160014Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- X-CORE 7180018Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- X-CORE 7180016Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- GIZA Corpectomy implant Giza, Diam 14 mm, 18-22 mm, 2-5 DegEden Spine Europe SA · Spinal Vertebral Body Replacement Device1 recall0 reports
- GIZA Corpectomy implant Giza, Diam 14 mm, 23-32 mm, 2-5 DegEden Spine Europe SA · Spinal Vertebral Body Replacement Device1 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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