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PDS Plates ZFP6Recalls & reported problems

Ethicon Inc. · PDS FLEX PLATE 0.50X40X50MM NASAL IMPLANT · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705031132528), received between Jul 24, 2021 and Jul 24, 2021 — classified as 1 injury.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Calcium Deposits/Calcification1
  • Fibrosis1
  • Inflammation1
  • Necrosis1
  • Visual Disturbances1

Recent adverse event reports

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

  • InjuryJul 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT ORBITAL FLOOR FRACTURE REPAIR ON (B)(6) 2021 AND THE FLEXIBLE PLATE WAS USED IN THE ORBIT. THE PATIENT DEVELOPED A LARGE MASS, 18X26X33MM, OF FIBROTIC TISSUE SURROUNDING THE IMPLANT WITHIN 8 DAYS AFTER SURGERY. HISTOPATHOLOGY SHOWED FIBROADIPOSE TISSUE WITH EXTENSIVE FAT NECROSIS, ORGANIZING BLOOD, FOCAL CALCIFICATION, AND EARLY SCAR. THE PHYSICIAN OPINED THAT IT WAS AN INFLAMMATORY REACTION TO THE IMPLANT. ALSO, IT WAS REPORTED THE FLEXIBLE PLATE WAS FIXATED TO THE INFEROLATERAL ORBITAL WALL WITH CYANOACRYLATE TOPICAL SKIN ADHESIVE, SO MAY POTENTIALLY HAVE BEEN SOME CHEMICAL REACTION. PATIENT EXPERIENCED SEVERE SUPRADUCTION RESTRICTION WITH DIPLOPIA IN UPGAZE. AT 14 DAYS POSTOP, THE IMPLANT WAS REMOVED, THE FIBROTIC TISSUE WAS RESECTED, AND THE ORBITAL FLOOR WAS REPAIRED WITH A POROUS POLYETHYLENE IMPLANT. FOR THE PATIENT RECOVERY, MAXITROL DROPS 4 TIMES A DAY. CURRENTLY THE PATIENT IS EXPERIENCING PERSISTENT UPGAZE RESTRICTION AND UNDERGOING SERIAL 5- FU INJECTIONS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Patient problems: Calcium Deposits/Calcification; Fibrosis; Inflammation; Necrosis; Visual Disturbances

    MAUDE report 12222555 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.