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MANTIS 48285640Recalls & reported problems

Stryker Corporation · CANNULATED SCREW · 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 04546540514561), received between Aug 25, 2016 and Aug 25, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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

  • Break1
  • Fracture1

Patient problems

  • No Code Available1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionAug 25, 2016Break; Fracture; Fracture

    IT WAS REPORTED THAT; ON (B)(6) 2015, THE PATIENT UNDERWENT THE SURGERY (T11-12-L1-3-4, L2 VERTEBROPLASTY). ON (B)(6) 2016, THE PATIENT UNDERWENT THE REMOVING SURGERY. THE SURGEON FOUND THAT THE SCREW SHAFT WAS BROKEN(L4 RIGHT). THEREFORE THE SURGEON REMOVED THE SCREW AND BROKEN PIECE.

    Patient problems: No Code Available; No Known Impact Or Consequence To Patient

    MAUDE report 5903424 ↗

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