SynPOR 08.510.120SRecalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 10887587026039), received between Jul 20, 2022 and Oct 21, 2025 — classified as 47 malfunctions.

The most frequently reported specific device problem is “Break” (42 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 25 most recent of 47 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 21, 2025Material Discolored; No Apparent Adverse Event; Material Discolored; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING THE SURGERY, UPON OPENING THE PACKING, IT WAS NOTED THAT THE DEVICE WAS BROKEN OFF AND HAD YELLOWING DISCOLORATION. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23347529 ↗
• MalfunctionJun 9, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING THE SURGERY, OPENED THE PACKING, THE DEVICE WAS FOUND TO BE TOO SOFT AND UNSUPPORTED(AS THE ATTACHED VIDEO SHOWS). ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22168885 ↗
• MalfunctionApr 25, 2025Break; Break

  IT WAS REPORTED THAT BEFORE THE SURGERY, SYNPOR PACKAGING WAS OPENED AND IT WAS NOTED THAT THE DEVICE HAD A HOLE IN IT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21911743 ↗
• MalfunctionJan 3, 2025Break; Break

  IT WAS REPORTED THAT BEFORE A NASAL SURGERY, IT WAS NOTED THE DEVICE WAS BROKEN OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21072601 ↗
• MalfunctionJan 3, 2025Break; Break

  IT WAS REPORTED THAT BEFORE A NASAL SURGERY, IT WAS NOTED NOTED THE DEVICE WAS BROKEN OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21072574 ↗
• MalfunctionJan 3, 2025Break; Break

  IT WAS REPORTED THAT BEFORE A NASAL SURGERY, IT WAS NOTED THE DEVICE WAS BROKEN OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21072496 ↗
• MalfunctionJan 3, 2025Break; Break

  IT WAS REPORTED THAT BEFORE A NASAL SURGERY, IT WAS NOTED THE DEVICE WAS BROKEN OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21072382 ↗
• MalfunctionFeb 5, 2024Device Damaged Prior to Use; Device Damaged Prior to Use

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CHINA AS FOLLOWS: IT WAS REPORTED ON (B)(6)2023, THAT DURING THE SURGERY, OPENED THE PACKING, NOTED THE EDGES WERE ROUGH AND THERE WAS A HOLE IN THE DEVICE (AS THE PHOTO SHOWS). ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS NO SURGICAL DELAY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS REPORT IS FOR ONE (1) SYNPOR SQUARE SHEET-SILE 50X50/0.8 THICK THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18642059 ↗
• MalfunctionJul 19, 2023Break; Break

  DEVICE REPORT FROM CHINA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2023, IT WAS NOTICED THAT THE DEVICE IN QUESTION WAS BROKEN. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR A SYNPOR SQUARE SHEET-STERILE 50MMX50MM/0.8MM THICK. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17349327 ↗
• MalfunctionJul 18, 2023Break; Break

  DEVICE REPORT FROM CHINA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2023, IT WAS NOTICED THAT THE DEVICE IN QUESTION WAS BROKEN. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR A SYNPOR SQUARE SHEET-STERILE 50MMX50MM/0.8MM THICK. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17344585 ↗
• MalfunctionMay 24, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CHINA 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. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO SURGICAL DELAY. THIS IS REPORT 1 OF 1 (B)(4). THIS REPORT IS FOR (1) SYNPOR SQUARE SHEET-STERILE 50MMX50MM/0.8MM THICK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16991332 ↗
• MalfunctionApr 19, 2023Break; Break

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN CHINA AS FOLLOWS: BREAKAGE. IT WAS REPORTED ON (B)(6) 2023, THAT DURING THE SURGERY, THE SURGEON OPENED THE PACKING AND NOTED THE DEVICE WAS BROKEN OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS REPORT IS FOR ONE (1) SYNPOR SQUARE SHEET-SILE 50X50/0.8 THICK THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16768404 ↗
• MalfunctionApr 18, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CHINA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2023, DURING THE SURGERY THE DEVICE WAS FOUND BROKEN. SECOND SET OF DEVICE WAS USED TO CONTINUE THE SURGERY, BUT THE SAME PROBLEM HAPPENED AGAIN. THIRD SET DEVICE WAS USED TO COMPLETE THE SURGERY. NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS REPORT IS FOR ONE (1) SYNPOR SQUARE SHEET-STERILE 50MMX50MM/0.8MM THICK. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16765638 ↗
• MalfunctionApr 18, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CHINA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, DURING THE SURGERY THE DEVICE WAS FOUND BROKEN. SECOND SET OF DEVICE WAS USED TO CONTINUE THE SURGERY, BUT THE SAME PROBLEM HAPPENED AGAIN. THIRD SET DEVICE WAS USED TO COMPLETE THE SURGERY. NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS REPORT IS FOR ONE (1) SYNPOR SQUARE SHEET-STERILE 50MMX50MM/0.8MM THICK. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16765635 ↗
• MalfunctionApr 18, 2023Break; Break

  THERE WAS NO DELAY IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16765632 ↗
• MalfunctionApr 18, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CHINA AS FOLLOWS: BREAKAGE. IT WAS REPORTED ON (B)(6) 2022, THAT DURING THE SURGERY, THE DEVICE WAS NOTED TO HAVE BROKEN OFF. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS NO SURGICAL DELAY. THE SURGERY WAS SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS REPORT IS FOR ONE (1) SYNPOR SQUARE SHEET-SILE 50X50/0.8 THICK. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16765123 ↗
• MalfunctionApr 18, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CHINA AS FOLLOWS: BREAKAGE. IT WAS REPORTED ON (B)(6) 2022, THAT DURING THE SURGERY, THE DEVICE WAS NOTED TO HAVE BROKEN OFF. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS NO SURGICAL DELAY. THE SURGERY WAS SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS REPORT IS FOR ONE (1) SYNPOR SQUARE SHEET-SILE 50X50/0.8 THICK THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16765089 ↗
• MalfunctionApr 17, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CHINA AS FOLLOWS: IT WAS REPORTED THAT DURING A RHINOPLASTY SURGERY ON (B)(6) 2023, DURING CUTTING, IT WAS NOTED THAT THE DEVICE WAS BROKEN OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY, AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THERE WAS NO DELAY TO SURGERY. NO FRAGMENTS WERE RETAINED IN THE PATIENT. THIS REPORT INVOLVES ONE SYNPOR SQUARE SHEET-STERILE 50MMX50MM/0.8MM THICK. THIS IS REPORT 1 OF 1 FOR PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16750371 ↗
• MalfunctionApr 14, 2023Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CHINA AS FOLLOWS: BREAKAGE. IT WAS REPORTED THAT DURING THE SURGERY ON (B)(6) 2023, DURING CUTTING, THE DEVICE BROKE. 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 (B)(4). THIS REPORT IS FOR SYNPOR SHEET 50*50 T0.8.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16745198 ↗
• MalfunctionApr 14, 2023Break; Material Discolored; Break; Material Discolored

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CHINA AS FOLLOWS: DISCOLORATION& HOLE IN DEVICE: IT WAS REPORTED THAT BEFORE THE SURGERY ON (B)(6) 2022, WHILE OPENING THE PACKING, THE PRODUCT WAS YELLOW AND HAD A HOLE IN DEVICE. PARTICLES WERE FALLING OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 1 OF 1 FOR (B)(4).THIS REPORT IS FOR ONE SYNPOR SQUARE SHEET-SILE 50X50/0.8 THICK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16744528 ↗
• MalfunctionApr 14, 2023Break; Peeled/Delaminated; Break; Peeled/Delaminated

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CHINA AS FOLLOWS: IT WAS REPORTED THAT DURING A RHINOPLASTY SURGERY ON (B)(6) 2023, 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 PC-(B)(4). THIS REPORT IS FOR ONE SYNPOR SHEET 50*50 T0.8.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16743885 ↗
• MalfunctionApr 14, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CHINA AS FOLLOWS: BREAKAGE. IT WAS REPORTED THAT DURING THE SURGERY, OPEN THE PACKAGING, NOTED THE DEVICE WAS BROKEN OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS NO SURGICAL DELAY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS REPORT IS FOR ONE (1) SYNPOR SQUARE SHEET-SILE 50X50/0.8 THICK THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16743387 ↗
• MalfunctionApr 14, 2023Break; Contamination /Decontamination Problem; Break; Contamination /Decontamination Problem

  IT WAS REPORTED THAT DURING A RHINOPLASTY SURGERY ON (B)(6) 2022, 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 (B)(4). THIS REPORT IS FOR SYNPOR SHEET 50*50 T0.8.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16742786 ↗
• MalfunctionApr 14, 2023Break; Peeled/Delaminated; Break; Peeled/Delaminated

  IT WAS REPORTED THAT DURING A RHINOPLASTY SURGERY ON (B)(6) 2022, 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 (B)(4).THIS REPORT IS FOR SYNPOR SHEET 50*50 T0.8.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16742711 ↗
• MalfunctionApr 14, 2023Break; Peeled/Delaminated; Break; Peeled/Delaminated

  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 (B)(4). THIS REPORT IS FOR SYNPOR SHEET 50*50 T0.8.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16742630 ↗