VARIAX 628526SRecalls & reported problems
Stryker GmbH · Hook Plate · Class 2 · Implant
All models of VARIAX (345)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327085549), received between Nov 15, 2018 and Feb 20, 2024 — classified as 3 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Device Dislodged or Dislocated1
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Failure of Implant2
- Erosion1
- Injury1
- Pain1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryFeb 20, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
AS REPORTED: "THE PATIENT'S BONE QUALITY WAS FRAGILE AND THE PLATE WAS DISLODGED FROM THE BONE ALONG WITH THE SCREWS. REVISION SURGERY IS PLANED ON (B)(6) 2024."
Patient problems: Failure of Implant
MAUDE report 18738940 ↗InjuryDec 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED, THAT ON (B)(6) . HOOK PLATE (B)(4) HOLE / 16MM / LEFT WAS USED. AFTER TWO AND A HALF MONTHS, PATIENT FELT A LITTLE PAIN. AFTER (B)(4) MONTHS, EROSION OF SUBACROMIAL HAPPENED BECAUSE OF HOOK, VARIAX CLAVICLE HOOK WAS EXPLANTED.
Patient problems: Erosion; Injury; Pain
MAUDE report 9513700 ↗InjuryNov 15, 2018Device Dislodged or Dislocated
FIXED SHOULDER JOINT DISLOCATION WITH THE VARIAX PLATE ON MAY 31. AS THE HOOK TIP BITES INTO THE SHOULDER PEAK GRADUALLY, IT LEADS TO REMOVAL BEFORE COMPLETELY CUTTING OUT. IT PULLED OUT ON OCTOBER 18TH.
Patient problems: Failure of Implant
MAUDE report 8075003 ↗
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- PRECICE® Plating System LP4.5-DRF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls1 report
- PRECICE® Plating System LP4.5-PLF40Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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