PROFYLE 59-23013Recalls & 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 34546540244896), received between Nov 24, 2021 and Nov 24, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Device Dislodged or Dislocated1
Patient problems
- Failure of Implant1
- Implant Pain1
- Swelling/ Edema1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 24, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED: "ON (B)(6), 2015. THE PATIENT'S LEFT HAND WAS INJURED BY A MACHINE ACCIDENTALLY AT HOME. FINALLY, DOCTOR DIAGNOSED THAT PATIENT¿S LEFT THUMB AND INDEX FINGER WERE NOT COMPLETELY SEVERED. ON (B)(6), 2015 , LEFT HAND DEBRIDEMENT, THUMB REPLANTATION, MIDDLE FINGER EXTENSOR TENDON REPAIR, BACK OF HAND AVULSION SKIN REPAIR, FOREIGN BODY REMOVAL, VSD DRAINAGE. THE MEDICAL OPERATION WAS SUCCESSFULLY. RECENTLY, THE PATIENT HAD LOCAL PROTRUSION OF THE PROXIMAL SEGMENT OF THE INDEX FINGER WITH SWELLING AND PAIN FOR MORE THAN 20 DAYS. ON (B)(6) 2021, PATIENT PERFORMED X RAY. THE IMAGE SHOW THAT PROXIMAL INDEX FINGER WAS FIXED WITH PLATE SCREWS AFTER MULTIPLE FRACTURES OF THE LEFT HAND. B ULTRASONOGRAPHY: SCREW ECHO IN THE PROXIMAL RADIAL SEGMENT OF THE LEFT INDEX FINGER. A PLATE SCREW INTERNAL FIXATION WAS PERFORMED TO REMOVE A BONE SCREW AND A PLATE." ADDITIONAL INFORMATION RECEIVED - (B)(6) 2021 THE PATIENT WENT TO THE DOCTOR AGAIN ON (B)(6) 2021 DUE TO LOCAL PROTRUSION AND REDNESS OF THE PROXIMAL INDEX FINGER. THE PATIENT HAS PERFORMED REVISION SURGERY, THE PLATE HAD BEEN REMOVED FROM PATIENT AND SCRAPPED BY HOSPITAL AS MEDICAL WASTE. ACCORDING TO THE DOCTOR'S PHYSICAL EXA
Patient problems: Failure of Implant; Implant Pain; Swelling/ Edema
MAUDE report 12867604 ↗
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- PRECICE® Plating System LP4.5-DRF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls1 report
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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 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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