SynPORRecalls & reported problems across all models

We found 9 models of SynPOR by Synthes GmbH in the FDA's device registry (GUDID). Together they are named in 66 adverse event reports in the FDA's MAUDE database, received between Feb 14, 2019 and Oct 21, 2025 — classified as 6 injuries, 60 malfunctions.

The most frequently reported specific device problem is “Break” (54 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported SynPOR problems

SynPOR models

9 models, most reported first. Each model has its own page with its reports, recalls and device details.

• SynPOR 08.510.120S

  Mesh, surgical
  47 reports
• SynPOR 08.510.220S

  Mesh, surgical, polymeric
  5 reports
• SynPOR 08.520.221S

  Mesh, surgical
  5 reports
• SynPOR 08.510.640S

  Mesh, surgical, polymeric
  2 reports
• SynPOR 08.520.120S

  Plate, cranioplasty, preformed, alterable
  2 reports
• SynPOR 08.520.220S

  Mesh, surgical
  2 reports
• SynPOR 08.510.110S

  Mesh, surgical
  1 report
• SynPOR 08.510.540S

  Mesh, surgical, polymeric
  1 report
• SynPOR 08.510.546S

  Mesh, surgical
  1 report

Recent SynPOR adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionJul 16, 2024Break; Break

  IT WAS REPORTED THAT ON JUNE 18, 2024, DURING THE SURGERY, THE DEVICE WAS FOUND TO HAVE A HOLE. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS NO SURGICAL DELAY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THIS REPORT INVOLVES ONE (1) SYNPOR SQUARE SHEET-STERILE 50MMX50MM/0.45MM THICK. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19749211 ↗
• 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 ↗
• 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 ↗
• 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 21, 2023Break; Break

  DEVICE REPORT FROM CHINA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A RHINOPLASTY PROCEDURE ON (B)(6) 2023, A SYNPOR PLATE BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THERE WAS NO SURGICAL DELAY. THIS REPORT IS FOR A SYNPOR FAN PLATE 35MM/0.8MM THICK-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17370957 ↗
• 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 ↗
• 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 ↗

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