Reform MC Screw System 59-MS-0061Recalls & reported problems
Precision Spine, Inc. · Cannulated Adjustment Driver · Class 1
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 00840019932448), received between Jun 3, 2021 and Jun 3, 2021 — classified as 1 injury.
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.
Most reported problems
Device problems
- Break1
- Improper or Incorrect Procedure or Method1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 3, 2021Break; Improper or Incorrect Procedure or Method
IT WAS REPORTED THE A PROCEDURE WAS PERFORMED ON AN UNKNOWN DATE, UTILIZING THE REFORM MIDLINE CORTICLE SCREW SYSTEM. THE DOCTOR WAS ATTEMPTING TO TIGHTEN A LOCK SCREW, AFTER IT HAD ALREADY BEEN TIGHTENED, USING THE CANNULATED ADJUSTMENT DRIVER (59-MS-0061) AND TORQUE LIMITING HANDLE WHEN THE TIP OF THE DRIVER BROKE.THE BROKEN TIP PIECE WAS NOT ABLE OT BE REMOVED AND REMAINS IN THE LOCK SCREW, IMPLANTED IN THE PATIENT. ACCORDING TO THE DISTRIBUTION THE DOCTOR KNEW IT WAS HIS FAULT THAT THE TIP BROKE.THERE WAS NO DELAY THE PROCEDURE REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 11931508 ↗
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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