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Vitoss 2102-1401Recalls & reported problems

Stryker Corporation · Bone Graft Substitute, Foam Pack, Beta-Tricalcium Phosphate and Type I Bovine Collagen · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00808232000412), received between Aug 29, 2017 and Aug 29, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Human Factors Issue” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Human Factors Issue1

Patient problems

  • Fatigue1
  • Reaction1

Recent adverse event reports

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

  • MalfunctionAug 29, 2017Human Factors Issue; Human Factors Issue; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT; PATIENT CAME IN FOR FOLLOW-UP. UNSPECIFIC SYMPTOMS AND LOCAL THROAT SOFT TISSUE TURGOR, ABNORMAL FATIGUE AND LISTLESSNESS IN TIMELY CONNECTION WITH THE CERVICAL SPINE SURGERY. FOR A DIFFERENTIAL DIAGNOSTIC A POTENTIAL ALLERGY REACTION ON THE IMPLANT COULD BE POSSIBLE.

    Patient problems: Fatigue; Reaction

    MAUDE report 6827776 ↗

Other FILLER, BONE VOID, CALCIUM COMPOUND devices

All FILLER, BONE VOID, CALCIUM COMPOUND devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.