SU-POR Surgical Implant 4028Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00815285022698), received between Sep 27, 2023 and Sep 27, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Off-Label Use” (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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 27, 2023Off-Label Use; Off-Label Use

  DURING INITIAL IMPLANTATION, A 14MM SPHERE WAS PLACED AND OPERATING SURGEON DESCRIBED DIFFICULTY SUTURING PATIENTS MUSCLES AND COVING THE IMPLANT WITH ADEQUATE SOFT TISSUE. THE SURGEON ATTEMPTED INTERVENTION THREE TIMES TO INCREASE SOFT TISSUE COVERAGE AND PROMOTE HEALING, BUT WAS UNABLE TO ADEQUATELY COVER THE DEVICE. THE PATIENT HAD PREVIOUSLY UNDERGONE RADIATION THERAPY ON THE SOFT TISSUES AND SURGEON DESCRIBED FAILURE DUE TO FAILURE OF THE SOFT TISSUES. ON JULY 25TH THE 14MM SPHERE WAS EXPLANTED AND A 16MM QUADRO-PORT SPHERE WAS PLACED. THE SURGEON WAS ABLE TO SUTURE THE MUSCLES TO THE REPLACEMENT DEVICE AND NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.

  Patient problems: Impaired Healing; Wound Dehiscence

  MAUDE report 17825253 ↗