SynPOR 08.510.640SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10887587026244), received between Oct 7, 2020 and Mar 13, 2024 — classified as 1 injury, 1 malfunction.

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 18, 2026.

Most reported problems

Recent adverse event reports

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

• InjuryMar 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, A SYNPOR ORBITAL FLOOR PLATE WAS USED TO FIX AN ORBITAL FLOOR FRACTURE THAT RESULTED IN A PATIENT INFECTION THAT WAS DETECTED AT A POST-OPERATIVE FOLLOW-UP. THERE WERE CONSEQUENCES, AS AN INFECTION OCCURRED IN THE PATIENT AFTER SURGERY. THIS REPORT IS FOR ONE (1) SYNPOR SMOOTH ORBITAL FLOOR PL 24/0.8 -S. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 18895707 ↗
• MalfunctionOct 7, 2020Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, THE FILM FROM POLYETHYLENE IMPLANT THAT WAS SUPPOSED TO BE ON TOP OF THE SYNPOR SMOOTH ORBITAL FLOOR PLATE WAS DELAMINATED AND PEELING OFF. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE USE OF ANOTHER IMPLANT. THERE WAS NO SURGICAL DELAY, AND NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) SYNPOR SMOOTH ORBITAL FLOOR PLATE 24MM/0.8MM THK-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10645362 ↗