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VARIAX 629246Recalls & reported problems

Stryker GmbH · Distal Posterior Lateral Humerus Plate · Class 2 · Implant

All models of VARIAX (345)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613154970575), received between Aug 21, 2019 and Aug 5, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Detachment of Device or Device Component1
  • Device Dislodged or Dislocated1
  • Migration1

Patient problems

  • Failure of Implant1
  • Injury1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • 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 (B)(6)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 O.R. : 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 10369305 ↗
  • InjuryAug 21, 2019Detachment of Device or Device Component; Migration; Migration

    IT WAS REPORTED THAT THE PATIENT'S LEFT DISTAL HUMERUS WAS REVISED. THE PROXIMAL END OF THE PLATE PULLED OFF THE BONE. THREE SCREW HEADS PASSED THROUGH THE HOLES IN THE PLATE AND REMAINED IN THE BONE. SURGEON REPORTED THAT NO TRAUMA HAD TAKEN PLACE PRIOR TO REVISION.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8914881 ↗

Other PLATE, FIXATION, BONE devices

All PLATE, FIXATION, BONE devices →

Sources and updates

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