VARIAX 657324Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327086980), received between Aug 5, 2020 and Nov 24, 2020 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (5 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 24, 2020Positioning Failure; Positioning Failure

  AS REPORTED: "NO BLOCKING WAS POSSIBLE. REPLACEMENT WAS AVAILABLE. SURGICAL DELAY OF 15MIN. NOT LONGER."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10891640 ↗
• MalfunctionSep 25, 2020Positioning Failure; Material Fragmentation; Positioning Failure; Material Fragmentation

  AS REPORTED: "ANGULAR STABILITY DID NOT WORK. SCREWS HAVE OVERRUN AND CHIPS HAVE COME LOOSE UNDER THE SCREW HEAD (UNFORTUNATELY, CHIPS COULD NOT BE SECURED). REPLACEMENT WAS AVAILABLE. PATIENT INVOLVEMENT WAS REPORTED BUT THE REPORTER IS NOT AWARE OF ANY IMPACT."

  Patient problems: Foreign Body In Patient

  MAUDE report 10586229 ↗
• MalfunctionSep 25, 2020Positioning Failure; Material Fragmentation; Positioning Failure; Material Fragmentation

  AS REPORTED: "ANGULAR STABILITY DID NOT WORK. SCREWS HAVE OVERRUN AND CHIPS HAVE COME LOOSE UNDER THE SCREW HEAD (UNFORTUNATELY, CHIPS COULD NOT BE SECURED). REPLACEMENT WAS AVAILABLE. PATIENT INVOLVEMENT WAS REPORTED BUT THE REPORTER IS NOT AWARE OF ANY IMPACT."

  Patient problems: Foreign Body In Patient

  MAUDE report 10586228 ↗
• MalfunctionSep 25, 2020Positioning Failure; Material Fragmentation; Positioning Failure; Material Fragmentation

  "ANGULAR STABILITY DID NOT WORK. SCREWS HAVE OVERRUN AND CHIPS HAVE COME LOOSE UNDER THE SCREW HEAD (UNFORTUNATELY, CHIPS COULD NOT BE SECURED). REPLACEMENT WAS AVAILABLE. PATIENT INVOLVEMENT WAS REPORTED BUT THE REPORTER IS NOT AWARE OF ANY IMPACT."

  Patient problems: Foreign Body In Patient

  MAUDE report 10586221 ↗
• MalfunctionAug 31, 2020Positioning Failure; Material Fragmentation; Positioning Failure; Material Fragmentation

  INTRAOPERATIVE DETECTION OF INADEQUATE SCREW RETENTION WITH CONSIDERABLE FORMATION OF METAL SPLINTERS.

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 10474755 ↗
• InjuryAug 5, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE CUSTOMER REPORTED THAT: INSTALLATION OF THE PLATE WITH 9 SCREWS (4 AT THE TOP AND 5 AT THE BOTTOM) IN THE PATIENT ON (B)(6) 2020 AFTER REMOVAL OF OLD EQUIPMENT FOR SEPTIC PSEUDOARTHROSIS (INITIAL MATERIAL IMPLANTED IN SEPTEMBER 2019 FOR FRACTURE LEFT HUMERUS) AND SUPPLY OF ILIAC GRAFT. IN POST-OPERATIVE RESIN IMMOBILIZATION ANTEBRACHIAL-PALMAR AND ANTIBIOTIC THERAPY PROBABILISTIC IV THEN RELAY PER OS ON ANTIBIOGRAM. CONTROL RADIOGRAPHY ON (B)(6) 2020 SHOWING A DISPLACEMENT OF THE SCREWS AND THE PLATE WITH PASSAGE OF 2 SCREWS THROUGH THE PLATE (UPPER PART) AND 1 SCREW OUT OF THE PLATE (UPPER PART). DECISION TO REMOVE THE MATERIAL IN THE OPERATING ROOM: OPERATION ON (B)(6) 2020 AND THE INSTALLATION OF 2 NEW PLATES AND RESIN IMMOBILIZATION ANTEBRACHIAL-PALMAR. CONTINUED ANTIBIOTIC THERAPY. NEXT CHECK-UP SCHEDULED FOR (B)(6) 2020. SURGICAL REVISION WITH REMOVAL OF MATERIAL AND RETOOLING.

  Patient problems: Failure of Implant; Injury

  MAUDE report 10369300 ↗