N/A 5584334Recalls & reported problems
Medtronic Sofamor Danek, Inc. · DRIVER 5584334 FAS LOCK SLEEVE 5.5/6.0 · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00643169016149), received between Jun 19, 2024 and Aug 29, 2025 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Break” (6 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.
Reports received per month
Most reported problems
Device problems
- Break6
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 29, 2025Break; Break
INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, DISTRIBUTOR) REGARDING AN EVENT WH ICH OCCURRED POST AN UNKNOWN PROCEDURE IN A PATIENT. IT WAS REPORTED THAT THE DRIVER BROKE DOWN. DISASSEMBLED DURING WASHING, A LACK OF A LOCK THAT JOINS THE TWO PIECES IS OBSERVED. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22920432 ↗MalfunctionMay 13, 2025Break; Break
INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR FUSION SPINAL THERAPY. IT WAS REPORTED THAT THE DEVICE IS BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE BLUE LOCKING PIECE BROKE OFF. AND THE DEVICE WAS USED BEFORE, HENCE NOT AN INITIAL DEFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22011741 ↗MalfunctionJan 30, 2025Break; Break
INFORMATION WAS RECEIVED FROM A HEALTHCARE FACILITY VIA MANUFACTURER REPRESENTATIVE REGARDING A DRIVER USED FOR SCOLIOSIS CORRECTION WITH THORACO-LUMBAR FUSION. IT WAS REPORTED THAT THE DRIVER WAS BROKEN. PRODUCT WILL BE RETURNED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE PRODUCT DIDN'T COME IN CONTACT WITH THE PATIENT. ANOTHER SCREWDRIVER WAS USED FROM THE SET INSTEAD. THE SURGICAL TEAM NOTICED IT WAS BROKEN WHEN THEY TRIED TO ASSEMBLE IT WITH A HANDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21273330 ↗MalfunctionJan 26, 2025Break; Break
INFORMATION WAS RECEIVED FROM A USER FACILITY (UF) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT USED IN UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THE DRIVERS WERE BROKEN AND STRIPPED. THERE IS NO PATIENT INVOLVED IN THE EVENT AND NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21236958 ↗MalfunctionJan 25, 2025Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING LUMBAR FUSION FOR UNKNOWN INDICATION. IT WAS REPORTED THAT THE DRIVER BROKE. PRODUCT WILL BE RETURNED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21236224 ↗MalfunctionNov 25, 2024Material Deformation; Material Deformation
INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE DEVICE WAS DAMAGED. 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 20769409 ↗MalfunctionJun 19, 2024Break; Break
INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING SERVICING. IT WAS REPORTED THAT THE FAS DRIVER WAS BROKEN INTO PIECES. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19564821 ↗
Other SCREWDRIVER devices
- DELTA XTEND 2307-92-003Depuy (Ireland) · SCREWDRIVER751 reports
- EXPEDIUM 279712400Medos International Sàrl · SCREWDRIVER551 reports
- NA 314.467Synthes GmbH · SCREWDRIVER498 reports
- N/A 5584111Medtronic Sofamor Danek, Inc. · SCREWDRIVER492 reports
- QUICKSET 2274-47-000Depuy (Ireland) · SCREWDRIVER487 reports
- NA 03.130.010Synthes GmbH · SCREWDRIVER1 recall422 reports
- QUICKSET 2274-63-000Depuy (Ireland) · SCREWDRIVER404 reports
- EVOS 71175072Smith & Nephew, Inc. · SCREWDRIVER336 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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