SynPOR 08.510.220SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10887587026114), received between Aug 2, 2022 and Jun 7, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 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.

• MalfunctionJun 7, 2023Break; Peeled/Delaminated; Break; Peeled/Delaminated

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CHINA AS FOLLOWS: IT WAS REPORTED THAT THE DEBRIS FELL OFF & IT WAS A BREAKAGE. IT WAS REPORTED BEFORE THE SURGERY, AS THE PACKING WAS OPENED, SOME PARTICLES FALL OFF AND THE DEVICE WAS BROKEN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) SYNPOR SMOOTH SQUARE SHEET 50X50/0.8 -S. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17080964 ↗
• MalfunctionMay 24, 2023Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SOUTH KOREA AS FOLLOWS: IT WAS REPORTED THAT DURING THE RHINOPLASTY SURGERY ON (B)(6) 2023, WHILE OPENING THE PACKAGING, IT WAS NOTED THE DEVICE WAS BROKEN OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. A 2 MINUTE SURGICAL DELAY WAS NOTED. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS IS FOR (1) SYNPOR SMOOTH SQUARE SHEET 50MMX50MM/0.8MM THICK-STERILE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16991410 ↗
• MalfunctionApr 14, 2023Break; Contamination /Decontamination Problem; Break; Contamination /Decontamination Problem

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CHINA AS FOLLOWS: IT WAS REPORTED THAT DURING A RHINOPLASTY SURGERY ON (B)(6) 2021, IT WAS NOTED THE DEVICE WAS BROKEN OFF AND SOME PARTICLES FALL OFF FROM THE EDGE OF DEVICE. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO SURGICAL DELAY. THIS IS REPORT 1 OF 1 FOR 001322139. THIS REPORT IS FOR ONE (1) SYNPOR SMOOTH SQUARE SHEET 50X50/0.8 -S.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16743246 ↗
• MalfunctionApr 13, 2023Break; Peeled/Delaminated; Break; Peeled/Delaminated

  DEVICE REPORT FROM DEPUY SYNTHES, REPORTS AN EVENT IN CHINA AS FOLLOWS: IT WAS REPORTED THAT DURING THE SURGERY, NOTED THE DEVICE WAS BROKEN OFF AND SOME PARTICLES FALL OFF FROM THE EDGE OF DEVICE. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) SYNPOR SMOOTH SQUARE SHEET 50X50/0.8 -S. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16737109 ↗
• MalfunctionAug 2, 2022Device Damaged Prior to Use; Device Damaged Prior to Use

  DEVICE REPORT FROM CHINA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, DURING COMPREHENSIVE NASAL SURGERY, THE PRODUCT IN QUESTION WAS FOUND WITH MATERIAL DEFECTS. UPON OPENING THE PACKING, DELAMINATION OF THE ROUGH AND SMOOTH SURFACES WAS NOTED BY THE SPECIALIST, AND SOME PARTICLES CAME OFF THE COMPONENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A SYNPOR SMOOTH SQUARE SHEET 50MMX50MM/0.8MM THICK-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15147824 ↗