SynPOR 08.520.220SRecalls & reported problems
Synthes GmbH · SYNPOR SMOOTH TI REINFORCED FAN PLATE 0.8MM THICK-STERILE · Class 2 · Implant
All models of SynPOR (9)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10887587026404), received between Mar 25, 2021 and Feb 22, 2022 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
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
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Break1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SYNPOR PLATE HAD AN UNKNOWN SPECIFIC ISSUE. WHEN PATIENT LOOKS UP THEY CAN SEE PLATE. THE PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS COMPLAINT INVOLVES ONE(1) DEVICE SYNPOR SMOOTH TI REINFRCD FAN PL .8-S. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 13578398 ↗MalfunctionMar 25, 2021Break; Break
IT WAS REPORTED THAT ON (B)(6) 2021, THE SURGEON WAS CUTTING AND CONTOURING THE SYNPOR. SYNPOR DID NOT APPEAR TO BE DEFECTED ONCE OPENED. IT WAS NOT HYDRATED IN SALINE PRIOR TO CUTTING AND CONTOURING THE FIRST TIME. THE PORES ARE STARTING TO PEEL TO COME OUT BUT NOT SURE IF ITS DUE TO HEAD CUTTING OR CONTOURING IT. THE SURGEON USED THE SECOND PIECE AND OPEN ADDITIONAL ONE AND IT ENDED UP BEING FINE. THERE WERE NO FRAGMENTS GENERATED. THERE WAS A SURGICAL DELAY OF 10-15 MINUTES. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) SYNPOR SMOOTH TI REINFORCED FAN PL .8-S. THIS REPORT IS 1 OF 1 (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11572124 ↗
Other Mesh, surgical devices
- MEDPOR TITAN 81032Stryker Leibinger GmbH & Co. KG · Mesh, surgical1 recall1 report
- Peri-Guard PC1016NSynovis Life Technologies, Inc. · Mesh, surgical1 recall1 report
- SurgiMend® 606-200-020Tei Biosciences Inc. · Mesh, surgical1 recall0 reports
- SurgiMend® 606-005-001Tei Biosciences Inc. · Mesh, surgical1 recall0 reports
- SurgiMend® 606-300-008Tei Biosciences Inc. · Mesh, surgical1 recall0 reports
- SurgiMend® 606-200-016Tei Biosciences Inc. · Mesh, surgical1 recall0 reports
- SurgiMend® 606-300-021Tei Biosciences Inc. · Mesh, surgical1 recall0 reports
- SurgiMend® 606-206-007Tei Biosciences Inc. · Mesh, surgical1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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