N/A 7570923 (UDI 00613994236012)Recalls & reported problems
Medtronic Sofamor Danek, Inc. · DRIVER 7570923 REDUCTION RETAIN DRVR · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994236012), received between Aug 7, 2020 and Oct 6, 2020 — classified as 2 injuries.
The most frequently reported specific device problem is “Material Fragmentation” (2 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
- Material Fragmentation2
Patient problems
- Foreign Body In Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 6, 2020Material Fragmentation; Material Fragmentation
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SCREW USING DRIVERS FOR A SPONDYLOLISTHESIS L4-5 (INTRA-OP). IT WAS REPORTED TIPS OF BOTH DRIVERS BROKE OFF INTO THE HEAD OF THE SCREW. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THE INSTRUMENTS BROKE AND THERE WERE FRAGMENTS OF THE INSTRUMENTS REMAINING IN THE PATIENT I.E. THE TIPS OF THE BROKEN DRIVERS ARE IN THE SCREW HEAD. THE PRE- OP DIAGNOSIS WAS SPONDYLOLISTHESIS L4-5. NO ADDITIONAL TREATMENT OR SURGERY PERFORMED AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.
Patient problems: Foreign Body In Patient
MAUDE report 10633836 ↗InjuryAug 7, 2020Material Fragmentation; Material Fragmentation
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SCREW USING DRIVERS FOR A SPONDYLOLISTHESIS L4-5. IT WAS REPORTED TIPS OF BOTH DRIVERS BROKE OFF INTO THE HEAD OF THE SCREW. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THE INSTRUMENTS BROKE AND THERE WERE FRAGMENTS OF THE INSTRUMENTS REMAINING IN THE PATIENT I.E. THE TIPS OF THE BROKEN DRIVERS ARE IN THE SCREW HEAD. THE PRE- OP DIAGNOSIS WAS SPONDYLOLISTHESIS L4-5. NO ADDITIONAL TREATMENT OR SURGERY PERFORMED AS A RESULT OF THIS EVENT. THE PRODUCTS WERE REPLACED BY MEDTRONIC PRODUCTS. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.
Patient problems: Foreign Body In Patient
MAUDE report 10377873 ↗
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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