PROFYLE 59-23012Recalls & reported problems
Stryker GmbH · BONE SCREWS, CROSS-FIT, SELF-TAPPING · Class 2 · Implant
Data updated Oct 13, 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 34546540244889), received between Feb 28, 2020 and Feb 28, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Fracture1
Patient problems
- Device Embedded In Tissue or Plaque1
- Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 28, 2020Fracture; Fracture
AS REPORTED: "ON (B)(6) 2018 FIX TWO METABOLIC FRACTURES USING TWO PROFILE COMBO 2.3MM SCREWS. (NO PLATE USED, TWO SCREWS INSERTED ALONE). WITHDRAWAL OPERATION AFTER HEALING ON (B)(6) 2020 MAKES REMOVAL DIFFICULT. WHEN I TRIED TO REMOVE THE SCREW WITH THE REMOVAL SCREWDRIVER, BOTH HEADS WERE IMMEDIATELY BROKEN. WITHDRAWAL BECAME DIFFICULT, AND THE OPERATION WAS ONCE COMPLETED. ON THE SAME DAY, THE DEALER BROUGHT IN SYNTHES' BROKEN SCREW REMOVAL INSTRUMENT AND RE-OPERATED TO REMOVE ALL IMPLANTS."
Patient problems: Device Embedded In Tissue or Plaque; Injury
MAUDE report 9772363 ↗
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- PRECICE® Plating System LP4.5-MLT4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls5 reports
- PRECICE® Plating System LP4.5-MRT4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls3 reports
- PRECICE® Plating System LP4.5-PLF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls3 reports
- PRECICE® Plating System LP4.5-DRF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls1 report
- PRECICE® Plating System LP4.5-DRF32Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 reports
- PRECICE® Plating System LP4.5-PLT42Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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