Ascential ACP 1 48804414ARecalls & reported problems
Stryker Corporation · Variable Angle Self-Tapping Screw Set · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327122275), received between Jul 24, 2017 and Jul 24, 2017 — classified as 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.
Most reported problems
Device problems
- Break1
- Detachment Of Device Component1
- Entrapment of Device1
Patient problems
- Device Embedded In Tissue or Plaque1
- 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.
MalfunctionJul 24, 2017Break; Detachment Of Device Component; Entrapment of Device
IT WAS REPORTED THAT DURING INSERTION THE THREADED PORTION OF THE LOCKING MECHANISM BROKE OFF IN THE PLATE. SURGEON DECIDED AGAINST REMOVING THE SCREWS AND REPLACING PLATE (PER REP'S SUGGESTION). THREADED PORTION IS STUCK IN THE PLATE INSIDE THE PATIENT. OTHER PIECE OF THE LOCKING MECHANISM WILL BE RETURNED.
Patient problems: Device Embedded In Tissue or Plaque; No Consequences Or Impact To Patient
MAUDE report 6737554 ↗
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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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