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XIA I 03805001Recalls & reported problems

Stryker Corporation · ROD TO ROD CLAMP PARALLEL · 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 04546540147981), received between Mar 28, 2018 and Mar 28, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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

  • Loose or Intermittent Connection1
  • Positioning Problem1

Patient problems

  • 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.

  • MalfunctionMar 28, 2018Loose or Intermittent Connection; Loose or Intermittent Connection; Positioning Problem

    IT WAS REPORTED THAT A PATIENT WAS HOSPITALIZED FOR AN ARTHRECTOMY AND OSTEOTOMY WITH ARTHRODESIS FOR A SCOLIOSIS. THE DEVICE DID NOT HOLD THE 2 RODS CORRECTLY DESPITE MAXIMUM TIGHTENING. THE DEVICE WAS REPLACED. LATE MANAGEMENT OF THE PATIENT WITH A DELAY IN THE SURGERY WAS REPORTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7379620 ↗

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