NexGen Anterior Cervical Plate System 65-IN-0730Recalls & reported problems
Precision Spine, Inc. · Screw Retention Driver - T10 · 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 00840019937948), received between Aug 27, 2020 and Aug 27, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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
- Activation, Positioning or Separation Problem1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 27, 2020Activation, Positioning or Separation Problem
IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON AN UNSPECIFIED DATE, UTILIZING THE SLIMPLICITY HP ACP SYSTEM. FOLLOWING INSERTION OF A SCREW, THE T10 SELF-RETAINING DRIVER NEXGEN ACP (65-IN-0730) STUCK IN THE HEAD OF THE SCREW. THE DOCTOR JIGGLED THE DRIVER AND IT STILL DID NOT DISCONNECT FROM THE SCREW, BUT PULLED THE SCREW OUT OF THE BONE. A RESCUE SCREW THAT WAS READILY AVAILABLE IN THE SET WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT INJURY OR DELAY TO THE PROCEDURE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10461813 ↗
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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