Vivosorb 5x7 cmRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08717703990201), received between May 18, 2020 and May 18, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Material Protrusion/Extrusion” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 18, 2020Material Protrusion/Extrusion

  A POST-MARKET INVESTIGATOR-DRIVEN TRIAL IS CURRENTLY PERFORMED (AN ACADEMIC PROSPECTIVE INTERVENTIONAL COHORT STUDY WITH PATIENTS SUFFERING DUPUYTREN DISEASE) WITH MINIMAL INVASIVE SURGERY AND VIVOSORB IN ORDER TO IMPROVE DEFORMITY OF THE FINGER. THIS IS WITHIN THE SCOPE OF THE VIVOSORB INTENDED USE. AT THE 2-WEEK FOLLOW-UP VISIT, TWO PATIENTS EXPERIENCED PROTRUSION OF (PART OF) VIVOSORB. LIMITED INFORMATION FROM ONE PATIENT ONLY HAS BEEN OBTAINED, SEE BELOW: SURGERY BEGIN (B)(6) 2020. VIVOSORB WAS CUT INTO PIECES; PLACED ON MULTIPLE LOCATIONS AND FIXATED WITH SUTURES IN THE PALM OF THE HAND, VERY CLOSE UNDER THE SKIN AND NEAR THE WOUND BED. AT THE 2-WEEKS FOLLOW-UP AFTER SURGERY (B)(6) PROTRUSION OCCURRED FROM A PART OF THE VIVOSORB; PATIENT PICKED AT THE WOUND AND PULLED LOOSE PIECES OF PRODUCT. THE SURGEON CLEANED THE WOUND BED, REMOVED REMNANTS OF VIVOSORB, AND CLOSED THE WOUND. THE OTHER PIECES OF VIVOSORB ARE STILL IN PLACE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10064803 ↗