PRO-DENSE™ 87SR0050Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889797072755), received between Jul 28, 2021 and Jul 24, 2024 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Too Rigid or Stiff” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT UNDERWENT A DEVICE EXPLANT SURGERY DUE TO INFECTION. THE PATIENT RECEIVED A CEMENT SPACER.

  Patient problems: Unspecified Infection

  MAUDE report 19820418 ↗
• InjuryAug 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING FOLLOW UP WITH SURGEON THE PATIENT MENTIONED A CONCERNING APPEARANCE TO INCISION AFTER USED PRODENSE FOR CYST. IT APPEARED PATIENT HAD ALLERGIC REACTION TO SOMETHING AND PROPHYLACTICALLY PRESCRIBED BACTRIN. SKIN HAS A LOCALIZED ALLERGIC APPEARANCE W/DRAINAGE.

  Patient problems: Bacterial Infection; Hypersensitivity/Allergic reaction

  MAUDE report 17463531 ↗
• InjuryJun 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO TREAT INTRAOSSEOUS LESION/NEOPLASM OF THE THIRD METATARSAL PROXIMAL METAPHYSIS OF THE LEFT FOOT. A FEW WEEKS POST-OP THE PATIENT NOTICED SWELLING, BURNING THROBBING, GETS REALLY RED OR PURPLE/BLACK AT TIMES. PATIENT EXPERIENCES SPASM. PATIENT MENTIONED THAT SHE HAD NOTICED SOME SWELLING AND DISCOLORATION POST SURGERY BUT AREA WAS BANDAGED AND DIDN'T SEE HOW BAD IT WAS UNTIL THE 2 WEEK FOLLOW UP. PATIENT CANNOT PUT TOO MUCH WEIGHT ON THE FOOT, SHE IS IN A WALKING SHOE. PATIENT HAS AN ALLERGY TO LATEX AND BROMINE. PATIENT IS STILL BEING TREATED BY PRIMARY DOCTOR AND MEETING WITH A PAIN MANAGEMENT DOCTOR.

  Patient problems: Ambulation or Postural Difficulties; Burning Sensation; Cramp(s) /Muscle Spasm(s); Reaction to Medicinal Component of Device; Skin Discoloration; Swelling/ Edema

  MAUDE report 14628635 ↗
• MalfunctionJul 28, 2021Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED THAT THE PRODENSE HARDENED TOO QUICKLY AND WAS NOT ABLE TO BE INJECTED INTO THE PATIENT. THERE WAS A BACKUP SOLUTION FROM ANOTHER COMPANY THAT WAS ABLE TO BE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12237531 ↗