NA 02.100.006Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982028259), received between Dec 11, 2017 and Jun 6, 2023 — classified as 3 injuries.

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

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON WILL BE REMOVING A PUBIC SYMPHYSIS PLATE ON (B)(6)23. NO ADVERSE EVENTS OR ALLEGATIONS AGAINST THE DEVICES HAVE BEEN COMMUNICATED. THIS PLATE CONSTRUCT WAS REMOVED SUCCESSFULLY. IT WAS REMOVED BECAUSE OF A SUSPECTED INFECTION. THIS REPORT IS FOR ONE (1) 3.5MM PUBIC SYMPHYSIS PLATE 6 HOLES THIS IS REPORT 1 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 17073525 ↗
• InjuryOct 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE PATIENT UNDERWENT REMOVAL OF ONE(1) PUBIC SYMPHYSIS PLATE AND SIX(6) UNKNOWN CORTEX SCREWS DUE TO INFECTION. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THIS REPORT IS FOR ONE (1) 3.5MM PUBIC SYMPHYSIS PLATE 6 HOLES. THIS IS REPORT 1 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 12624625 ↗
• InjuryDec 11, 2017Break; Break

  IT WAS REPORTED DURING A PUBIC SYMPHYSIS REVISION SURGERY ON (B)(6) 2017, A BROKEN 3.5MM SYMPHYSIS PLATE, TWO (2) BROKEN 3.5MM LOCKING SCREWS AND A BROKEN 3.5MM CORTEX SCREW WERE REMOVED. THE PATIENT WAS EXPERIENCING PAIN AND THROUGH X-RAYS IT WAS REVEALED THAT THE PLATE AND SCREWS WERE BROKEN. THE INITIAL SURGERY INFORMATION IS UNKNOWN. THE SURGEON REPLACED THE BROKEN PLATE AND SCREWS WITH A 4.5MM SYNTHES RECON PLATE. THE REVISION SURGERY WAS A SUCCESS WITHOUT ANY DELAYS AND PATIENT OUTCOME WAS NOTED AS STABLE. CONCOMITANT DEVICE REPORTED: CORTEX SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 3) THIS REPORT IS FOR ONE (1) 3.5MM PUBIC SYMPHYSIS PLATE 6 HOLES. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant; Pain

  MAUDE report 7104955 ↗