NA 04.130.256SRecalls & reported problems
Synthes GmbH · 1.5MM TI VAL PHALANGEAL HEAD PLATE-RIGHT-STERILE · 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 10886982112996), received between Dec 12, 2024 and Dec 12, 2024 — 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.
Reports received per month
Most reported problems
Device problems
- Break1
- Entrapment of Device1
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.
MalfunctionDec 12, 2024Break; Entrapment of Device; Break; Entrapment of Device
IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN UNKNOWN SURGERY FOR METACARPAL ON MIDDLE FINGER WITH VA-HAND AND THE PRODUCTS IN QUESTION. IN THE SURGERY, THE HEADS OF THE SCREWS IN QUESTION WERE DAMAGED WHEN THE LAST FASTENING WAS ATTEMPTED. THE DRILL TIP WAS THEN DAMAGED WHEN DRILLING THE NEXT HOLE. THE DRILL TIP WAS ALSO BROKEN IN THE NEXT HOLE. THE SCREWS WITH A BROKEN HEADS AND TWO BROKEN DRILL TIPS HAVE BEEN IMPLANTED IN THE BODY AT THE SURGEON'S DISCRETION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 30 MINUTES SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Foreign Body In Patient
MAUDE report 20914119 ↗
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- HEALIX PEEK ORTHOCORD 222205Medos International Sàrl · Screw, fixation, bone186 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-225Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, 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 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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