FlexBand 31056Recalls & reported problems
Artelon · Dynamic Matrix · 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 00868047000380), received between Dec 16, 2024 and Dec 16, 2024 — 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Graft failure1
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED IN REVIEW OF MANUSCRIPT FOR PUBLICATION IDENTIFIED A DEEP INFECTION. "PATIENT DEVELOPED A DEEP POSTOPERATIVE INFECTION FOLLOWING A REVISION ORIF ANKLE FRACTURE WITH DELTOID LIGAMENT RECONSTRUCTION USING PUUR GRAFT, WHICH REQUIRED IRRIGATION AND DEBRIDEMENT AND GRAFT REMOVAL. OF THESE MAJOR COMPLICATIONS WITH RETURN TO THE OR, ONLY THE DEEP SURGICAL SITE INFECTION INVOLVED THE PUUR GRAFT."
Patient problems: Graft failure; Unspecified Infection
MAUDE report 20939524 ↗
Other Mesh, Surgical, Polymeric devices
- PROCEED PVPMJohnson & Johnson International Inc. · Mesh, surgical, polymeric1,233 reports
- PROCEED PCDN1Johnson & Johnson International Inc. · Mesh, surgical, polymeric744 reports
- PROCEED PCDG1Johnson & Johnson International Inc. · Mesh, surgical, polymeric1 recall1 death637 reports
- PROCEED PVPSJohnson & Johnson International Inc. · Mesh, surgical, polymeric622 reports
- ProGrip LPG1510Sofradim Production · Mesh, surgical, polymeric2 deaths616 reports
- VENTRALEX 0010302Davol Inc. · Mesh, surgical, polymeric4 deaths531 reports
- BARD 0112680Davol Inc. · Mesh, surgical, polymeric1 death494 reports
- ProGrip TEM1509GSofradim Production · Mesh, surgical, polymeric3 deaths471 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.