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OASYS 48551072Recalls & reported problems

Stryker Corporation · TRANSVERSE CONNECTOR · Class 2 · Implant

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

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540596093), received between Mar 13, 2017 and Mar 13, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Break2
  • Fracture2

Patient problems

  • No Known Impact Or Consequence To Patient2

Recent adverse event reports

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

  • MalfunctionMar 13, 2017Break; Fracture; Fracture

    IT WAS REPORTED THAT; DURING TIGHTENING OF TRANSVERSE CROSS CONNECTOR BOTTOM TABS BROKE OFF. THIS HAPPENED 8-10 TIMES WITH ALL SIZES OF CROSS CONNECTORS. PROPER TECHNIQUE WAS FOLLOW DURING TIGHTENED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6399645 ↗
  • MalfunctionMar 13, 2017Break; Fracture; Fracture

    IT WAS REPORTED THAT; DURING TIGHTENING OF TRANSVERSE CROSS CONNECTOR BOTTOM TABS BROKE OFF. THIS HAPPENED 8-10 TIMES WITH ALL SIZES OF CROSS CONNECTORS. PROPER TECHNIQUE WAS FOLLOWED DURING TIGHTENING.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6399638 ↗

Other APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices

All APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices →

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