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DCP 02.100.016Recalls & reported problems

Synthes GmbH · 3.5MM PUBIC SYMPHYSIS PLATE 6 HOLES INCL 2 DCP(TM) HOLES · Class 2 · Implant

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982028273), received between Feb 28, 2022 and Aug 5, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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

  • Adverse Event Without Identified Device or Use Problem1
  • Device-Device Incompatibility1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • Unspecified Infection1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT ON (B)(6) 2022 THERE WAS REMOVAL OF HARDWARE DUE TO INFECTION. THERE WAS NO SURGICAL DELAY. THE SURGERY WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS UNKNOWN. THIS REPORT IS FOR ONE (1) 3.5 PUBIC SYMPH PL 6 H INCL 2 DCP H. THIS IS REPORT 1 OF 7 FOR COMPLAINT (B)(4).

    Patient problems: Unspecified Infection

    MAUDE report 15176001 ↗
  • MalfunctionFeb 28, 2022Device-Device Incompatibility; Device-Device Incompatibility

    IT WAS REPORTED THAT ON (B)(6) 2022, DURING AN UNKNOWN PROCEDURE WHILE PLATING A PUBIC SYMPHYSIS, A LOCKING SCREW WOULD NOT LOCK INTO THE PLATE. THE SURGEON DECIDED TO REDIRECT A 3.5 CORTEX SCREW FOR BICORTICAL FIXATION. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS A SURGICAL DELAY OF FIVE (5) MINUTES. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 3.5MM PUBIC SYMPHYSIS PLATE 6 HOLES INCL 2 DCP(TM) HOLES THIS IS REPORT 1 OF 2 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13621215 ↗

Other PLATE, FIXATION, BONE devices

All PLATE, FIXATION, BONE devices →

Sources and updates

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