SynPOR 08.520.120SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10887587026343), received between Sep 27, 2021 and Mar 6, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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.

• MalfunctionMar 6, 2023Break; Crack; Break; Crack

  DEVICE REPORT FROM SOUTH KOREA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022 WHEN THE SURGEON OPENED THE SYNPOR, IT WAS DISCOVERED THAT SOME PARTS WERE DAMAGED. FRAGMENTS GENERATED WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AFTER A 5 MINUTE DELAY USING A SPARE REPLACEMENT PRODUCT FROM INVENTORY. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A SYNPOR TI REINFORCED FAN PLATE 0.8MM THICK-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16486792 ↗
• MalfunctionSep 27, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING THE SURGERY A SYNPOR TITANIUM REINFORCED FAN PLATE CAME APART. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT IS FOR ONE (1) SYNPOR TI REINFORCED FAN PLATE 0.8MM THICK-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12537565 ↗