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PlusDrive 400.453Recalls & reported problems

Synthes GmbH · 1.3MM TI CRTX SCREW SLF-DRLG W/PLUSDRIVE(TM) RECESS 3MM · 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 20887587043187), received between Jun 23, 2022 and Jun 23, 2022 — classified as 1 injury.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Break1

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.

  • InjuryJun 23, 2022Break; Break

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A FRONTAL BONE SHAVE DOWN, THE TIP OF A 1.3MM SCREW BROKE OFF IN THE PATIENT WHEN TRYING TO ENGAGE IN BONE. THERE WAS NO SURGICAL DELAY AND PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR (1) 1.3 TI CRTX SCR SLF-DRLG PD REC 3-5PK. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Patient problems: Foreign Body In Patient

    MAUDE report 14787262 ↗

Other PLATE, BONE devices

All PLATE, BONE devices →

Sources and updates

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