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SMARTLOCK 55-05765Recalls & reported problems

Stryker Leibinger GmbH & Co. KG · LOCKING L-PLATE, WITH 8MM BAR · Class 2 · Implant

All models of SMARTLOCK (17)

Data updated Oct 16, 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 04546540365712), received between Oct 19, 2018 and Oct 19, 2018 — classified as 1 malfunction.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Fracture1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionOct 19, 2018Fracture

    IT WAS REPORTED THAT A 6 MONTHS POSTOPERATIVE CLINICAL EXAMINATION SHOWED MOBILITY OF THE MAXILLARY BONE. ON (B)(6) 2018, A NEW SURGICAL PROCEDURE WAS PERFORMED TO EVALUATE THE FIXATION OF THE JAW AND A FRACTURE OF THE 2 FIXATION PLATES WAS OBSERVED ON THE LEFT SIDE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7986496 ↗

Other PLATE, BONE devices

All PLATE, BONE devices →

Sources and updates

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