Su-Por Surgical Implants 4353Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00815285021899), received between Oct 10, 2022 and Jan 5, 2026 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Expulsion” (2 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJan 5, 2026Patient-Device Incompatibility

  ON DECEMBER 8, 2025, THE SURGEON NOTIFIED PORIFEROUS REGARDING A PATIENT CASE INVOLVING AN IMPLANT INFECTION THAT REQUIRES A REVISION SURGERY. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT PROVIDED.

  Patient problems: Medical device site infection

  MAUDE report 23956954 ↗
• MalfunctionJan 5, 2026Fracture

  (B)(6) 2025, A SURGEON NOTIFIED PORIFEROUS OF A SURGICAL COMPLICATION REQUIRING THE FABRICATION OF A NEW IMPLANT. THE ORIGINAL IMPLANT, MANUFACTURED IN 2019, EXPERIENCED A FRACTURE AND WAS SUBSEQUENTLY REPLACED WITH AN IMPLANT FROM ANOTHER BRAND. THE REPLACEMENT IMPLANT IS NOW SCHEDULED FOR REMOVAL DUE TO UNKNOWN REASONS, AND A NEW SU-POR IMPLANT WILL BE PLACED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23956943 ↗
• InjuryNov 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MICROTIA REPAIR FOLLOWING TRAUMATIC LOSS OF EAR IN A CAR ACCIDENT. INITIAL IMPLANTATION: (B)(6) 2024, NO COMPLICATIONS AT THE TIME OF SURGERY. (B)(6) 2024 PATIENT WAS SEEN IN CLINIC NO SIGN OF INFECTION OR COMPLICATION. PATIENT WAS NOT FOLLOWING POST OPERATIVE CARE INSTRUCTIONS PROVIDED BY OPERATING SURGEONS. (B)(6) 2024 THE PATIENT PRESENTED WITH EXPOSURE. NO MEDICAL OR SURGICAL INTERVENTION TAKEN PLACE YET BUT IS PLANNED. WE WILL UPDATE WITH ADDITIONAL INFORMATION AS COLLECTED.

  Patient problems: Skin Erosion

  MAUDE report 20712282 ↗
• InjuryOct 1, 2024Mechanical Problem; Mechanical Problem

  AN IMPLANT WAS EXPLANTED DUE TO FRACTURE. ANOTHER IMPLANT WAS PLACED WITHIN THE SAME SURGERY WITH NO COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20346551 ↗
• InjuryApr 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT EXPERIENCED POST OPERATIVE EXPOSURE OF THE IMPLANT. SURGEON ATTRIBUTED THE EXPOSURE TO THE DRESSING AND PERFORMED INTERVENTION TO SALVAGE THE IMPLANT AND RESOLVE THE EXPOSURE.

  Patient problems: Skin Erosion

  MAUDE report 19072430 ↗
• InjuryFeb 24, 2023Expulsion; Expulsion

  PATIENT PRESENTED WITH PURULENT DRAINAGE COMING OUT OF THE EXPOSURE UPON PALPATION OF THE SURROUNDING AREA.

  Patient problems: Pocket Erosion; Post Operative Wound Infection

  MAUDE report 16436983 ↗
• InjuryFeb 13, 2023Expulsion; Expulsion

  PATIENT REPORTED TO PHYSICIAN'S OFFICE WITH AN EXPOSURE OF THE IMPLANT WITHOUT PRESENCE OF INFECTION. PHYSICIAN BEGAN TREATING PATIENT WITH DRESSING CHANGES TWICE DAILY. EXPLANTATION WAS PERFORMED ON (B)(6) 2023 AND A NEW IMPLANT WAS PLACED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Pocket Erosion

  MAUDE report 16364195 ↗
• InjuryOct 10, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IMPLANT WAS INITIALLY IMPLANTED (B)(6) 2022. PATIENT RETURNED TO OFFICE ON (B)(6) 2022 AND PRESENTED IWTH AN INFECTION. PHYSICIAN PRESCRIBED ORAL ANTIBIOTICS AND SUTURED WOUND CLOSED. ON (B)(6) 2022 USER FACILITY MADE CONTACT IWTH THE MANUFACTURER TO REPORT THAT THE INFECTION HAD NOT RESOLVED AND REOPERATION WAS SCHEDULED FOR (B)(6) 2022. DEVICE WAS EXPLANTED AND NEW DEVICE IMPLANTED WITH NO COMPLICATIONS.

  Patient problems: Infectious Otitis Externa

  MAUDE report 15571199 ↗