DFINERecalls & reported problems across all models

We found 3 models of DFINE by Merit Medical Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, received between Mar 6, 2020 and Mar 6, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (1 report).

2 FDA recall records name at least one of these models by its device identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

DFINE recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Feb 13, 2020Terminated

   Vertebral hydraulic assemblies has incorrect expiration date printed on the labels.The product's shelf-life is two (2) years, but the expiration date printed on the labels is five (5) years.The affected product will begin expiring in March 2020. Using product beyond the validated shelf-life may result in (1) product not functioning as intended and/or (2) a delay in procedure or the need for the procedure to be rescheduled.

   Z-2068-2020 · Root cause: Labeling Change Control · Recall details · FDA record ↗

2. Feb 13, 2020Terminated

   Vertebral hydraulic assemblies has incorrect expiration date printed on the labels.The product's shelf-life is two (2) years, but the expiration date printed on the labels is five (5) years.The affected product will begin expiring in March 2020. Using product beyond the validated shelf-life may result in (1) product not functioning as intended and/or (2) a delay in procedure or the need for the procedure to be rescheduled.

   Z-2067-2020 · Root cause: Labeling Change Control · Recall details · FDA record ↗

Most reported DFINE problems

DFINE models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• DFINE® 00884450374375

  Injector, vertebroplasty (does not contain cement)
  1 recall0 reports
• DFINE® 00884450374399

  Injector, vertebroplasty (does not contain cement)
  1 recall0 reports
• DFINE® 00884450296523

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  1 report

Recent DFINE adverse event reports

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

• MalfunctionMar 6, 2020Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A VERTEBRAL AUGMENTATION [KYPHOPLASTY] POST-PROCEDURE, THE TIP OF THE NAVIGATING OSTEOTOME DETACHED WITHIN THE PATIENT'S VERTEBRAL BODY. THE FIRST LEVEL AUGMENTATION WAS SUCCESSFUL. DURING THE SECOND LEVEL AUGMENTATION THE PHYSICIAN NOTICED THAT THE OSTEOTOME WOULD NOT ARTICULATE. AFTER A FEW MINUTES OF MANIPULATION, THE DEVICE WAS SUCCESSFULLY REMOVED HOWEVER, THE PHYSICIAN NOTED THAT THE TIP HAD DETACHED WITHIN THE PATIENT. THE TIP WAS NOT RETRIEVED FROM THE PATIENT'S VERTEBRAL BODY. FLUOROSCOPY DEMONSTRATED THAT THE BROKEN TIP WAS WEDGED WITHIN A VERTEBRAL PEDICLE. THE PHYSICIAN DID NOT WANT TO ATTEMPT A PEDICLE PLASTY. THE PATIENT WAS DISCHARGED WITHOUT ADDITIONAL CONSEQUENCES. THE PHYSICIAN WILL CONTINUE TO MONITOR.

  Patient problems: Foreign Body In Patient

  MAUDE report 9799476 ↗

Other Merit Medical Systems, Inc. products

• Aspira11 models · 36 reports · 10 recalls
• Impress145 models · 481 reports
• Monarch6 models · 37 reports · 7 recalls
• Bridge Prep Kit4 models · 6 reports · 3 recalls
• Prelude Roadster33 models · 1 reports · 3 recalls
• basixTOUCH6 models · 1 reports · 3 recalls
• basixCOMPAK34 models · 34 reports · 2 recalls
• Flex-Neck11 models · 21 reports · 2 recalls