Reform MC Screw System 59-SP-0601Recalls & reported problems
Precision Spine, Inc. · Adjustment Screw Driver · Class 1
Data updated Oct 18, 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 00840019927987), received between Feb 9, 2023 and Jul 23, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Entrapment of Device1
- Fracture1
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 23, 2024Fracture; Fracture
IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON (B)(6) 2024 UTILIZING THE REFORM MC SCREW SYSTEM. DURING THE PROCEDURE THE T25, ADJUSTABLE DRIVER; REFORM MC SCREW SYSTEM (59-SP-0601) TIP BROKE. THE BROKEN TIP WAS REMOVED FROM THE SCREW AND THE PROCEDURE WAS COMPLETED UTILIZING OTHER INTRUMENTATION READILY AVAILABLE. THERE WAS NO PATIENT INJURY, BUT A FIFTEEN (15) MINUTE DELAY TO THE PROCEDURE RESULTED FROM THE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19810827 ↗InjuryFeb 9, 2023Break; Entrapment of Device
IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON (B)(6) 2023, UTILIZING THE REFORM MC PEDICLE SCREW SYSTEM. WHILE ATTEMPTING TO ADJUST A SCREW, THE TIP OF THE ADJUSTABLE DRIVER (59-SP-0601) BROKE. THE BROKEN TIP PIECE WAS LEFT IN THE HEAD OF THE SCREW IMPLANTED IN THE PATIENT. THE PROCEDURE WAS COMPLETED UTILIZING OTHER INSTRUMENTATION, READILY AVAILABLE IN THE SET. THERE WAS NO DELAY TO THE PROCEDURE.
Patient problems: Foreign Body In Patient
MAUDE report 16336882 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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