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Off-Axis Driver Access Plug DAPRecalls & reported problems

Implant Direct Sybron Manufacturing LLC · Class 1 · Implant

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 10841307122968), received between Mar 6, 2020 and Mar 6, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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

  • Device Markings/Labelling Problem1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionMar 6, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

    PER COMPLAINT (B)(4), THE UDI NUMBER ON THE PRODUCT LABEL WAS INCORRECT. THIS IS AN INTERNAL COMPLAINT, THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9800302 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.