SynPOR 08.520.221SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10887587026428), received between Jul 18, 2019 and Apr 4, 2024 — classified as 3 injuries, 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, AFTER A FACIAL FRACTURE CASE, THE SURGEON LEARNED THAT THE PATIENT WAS HAVING VISION ISSUES. THE PRE-OP AND POST-OP VISION WERE INTACT. DURING SURGERY, SYNPOR WAS PLACED TO TREAT THE ORBITAL FLOOR FX. AN ORBITAL RIM TITANIUM PLATE WAS ALSO PLACED. CT IMAGING WAS DONE POST OP. LATE AT NIGHT, THE PATIENT WAS BROUGHT BACK TO THE OR TO REMOVE ORBITAL FLOOR PLATE WITH CONCERN OF A HEMATOMA. SURGEON REPORTED ON 3/19 THAT THE PATIENT HAS LOST VISION. THERE WAS ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY OR IF THERE WERE PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) SYNPOR SMO TI RNFRC FN PL FIXTN H/0.8-S THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding; Inflammation; Loss of Vision

  MAUDE report 19041679 ↗
• MalfunctionJan 12, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DISINTEGRATION OF A SYNPOR SMOOTH TITANIUM REINFORCED FAN PLATE WITH AN UNKNOWN PATIENT OCCURRED. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR (1) SYNPOR SMOOTH TI REINFORCED FAN PL FIXTN H/0.8MM THK-STER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13235640 ↗
• MalfunctionDec 30, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 DURING AN UNKNOWN OPHTHALMIC SURGERY, THE SYNPOR SMOOTH TI REINFORCED FAN PLATE WAS FOUND TO BE BROKEN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER DEVICE THERE WAS NO PATIENT CONSEQUENCE. THERE WAS NO SURGICAL DELAY. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR (1) SYNPOR SMOOTH TI REINFORCED FAN PL FIXTN H/0.8MM THK-STER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13120952 ↗
• InjuryJul 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A REMOVAL OF SYNPOR SMOOTH TITANIUM REINFORCED FAN PLATE & TITANIUM MATRIXMIDFACE SCREW SELF-DRILLING DUE TO INFECTION. PATIENT WAS INITIALLY TREATED ON AN UNKNOWN DATE FOR AN ORBITAL FLOOR FRACTURE. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS REPORT IS FOR A SYNPOR SMOOTH TITANIUM (TI) REINFORCED FAN PLATE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8807638 ↗
• InjuryJul 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REMOVAL PROCEDURE OF SYNPOR SMOOTH TITANIUM REINFORCED FAN PLATE & TITANIUM MATRIXMIDFACE SCREW SELF-DRILLING DUE TO INFECTION. ORIGINALLY THE PATIENT HAD AN ORBITAL FLOOR FRACTURE SURGERY ON (B)(6) 2019. IMPLANTS WERE REMOVED SUCCESSFULLY. PATIENT OUTCOME AFTER THE REMOVAL PROCEDURE IS UNKNOWN. THIS REPORT IS FOR ONE (1) SYNPOR SMOOTH TI REINFORCED FAN PLATE FIXATION. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8803604 ↗