5MS™ P62 ST416Recalls & reported problems
In2Bones USA, LLC · Plate Screw, Ø2.4 X 16 mm, Non-Locking · Class 2 · Implant
Data updated Oct 16, 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 00817906022148), received between Jan 7, 2026 and Jan 7, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Expiration Date Error” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Expiration Date Error1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 7, 2026Expiration Date Error
THE CONMED REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE P62 ST416 PLATE SCREW, Ø2.4 X 16 MM, NON-LOCKING DEVICE WAS BEING USED DURING A 5MS PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED ¿AN EXPIRED IMPLANT WAS IMPLANTED ON (B)(6) 2025. THE IMPLANT WAS P62 ST416 LOT NUMBER GM000944. THE EXPIRATION DATE ON THE PRODUCT WAS 27-OCTOBER-2025. THE PRODUCT WAS REMOVED FROM THE PATIENT ON (B)(6) 2025 BY THE SURGEON AS THE HOSPITAL NOTICED THE EXPIRATION DATE AFTER THE DEVICE WAS PLACED IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE USE OF THE SAME ALTERNATE DEVICE. THIS REPORT IS BEING RAISED ON THE REPORTED INJURY DUE TO THE PATIENT REQUIRING AN ADDITIONAL OPERATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23988442 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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