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SPS 430106Recalls & reported problems

Stryker GmbH · Reconstruction Plate; straight · 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 04546540368447), received between Nov 19, 2018 and Nov 19, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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.

Most reported problems

Device problems

  • Improper or Incorrect Procedure or Method1

Patient problems

  • No Code Available1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryNov 19, 2018Improper or Incorrect Procedure or Method

    THE CUSTOMER REPORTED THAT THE SURGEON IMPLANTED A RECON PLATE INSTEAD OF A WAISTED COMPRESSION PLATE INTO THE WRIST OF A PATIENT. THE ITEMS ARE POSITIONED IN SIMILAR PLACES ON THE SMALL FRAGMENT SET TRAY AND HAVE A SIMILAR APPEARANCE WHEN VIEWED SIDE BY SIDE AND AS SUCH THE WRONG PLATE WAS HANDED TO THE SURGEON IN ERROR. INDICATION FOR THE PRIMARY SURGERY: BOTH BONE MID/DISTAL 1/3RD FOREARM FRACTURE (RIGHT) FRACTURE NOT UNITED BUT IN REASONABLE ALIGNMENT AT 10 WEEKS. SIGNIFICANT RISK OF REQUIRING REVISION. UNDER REVIEW. 430106 IMPLANTED INSTEAD OF 430006.

    Patient problems: No Code Available

    MAUDE report 8084080 ↗

Other PLATE, FIXATION, BONE devices

All PLATE, FIXATION, BONE devices →

Sources and updates

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