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RADIUS 486614560Recalls & reported problems

Stryker Corporation · AXIAL ROD TO ROD CONNECTOR · Class 2 · Implant

Adverse event reports
4
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04546540546364), received between Jun 27, 2016 and Aug 11, 2016 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (4 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

  • Mechanical Problem4
  • Detachment of Device or Device Component2
  • Device Dislodged or Dislocated2
  • Device Slipped2

Patient problems

  • Injury4
  • No Code Available3
  • No Information1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 11, 2016Mechanical Problem; Detachment of Device or Device Component; Device Dislodged or Dislocated; Mechanical Problem; Detachment of Device or Device Component

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED FROM 5/19 CASE. RODS PULLED OUT FROM 5.5-6.0 CONNECTORS. WHEN FOLLOWING UP ON CASE WITH SURGEON, IT WAS STATED THAT THIS IS THE THIRD TIME THIS HAS HAPPENED WITH THE SAME CONNECTORS. THE SALES REP DO NOT HAVE KNOWLEDGE OR PREVIOUS CASES.

    Patient problems: Injury; No Code Available

    MAUDE report 5869093 ↗
  • InjuryJun 28, 2016Mechanical Problem; Device Dislodged or Dislocated; Mechanical Problem

    IT WAS REPORTED THAT THE PATIENT BENT OVER AND FELT A POP. X-RAY CONFIRMED THE ROD TO ROD CONNECTOR PULLED OUT.

    Patient problems: Injury; No Code Available

    MAUDE report 5756066 ↗
  • InjuryJun 27, 2016Mechanical Problem; Device Slipped; Mechanical Problem

    IT WAS REPORTED THAT THE ROD TO ROD CONNECTOR PULLED OUT POST OPERATIVELY.

    Patient problems: Injury; No Information

    MAUDE report 5753190 ↗
  • InjuryJun 27, 2016Mechanical Problem; Device Slipped; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED FROM (B)(6) CASE. RODS PULLED OUT FROM 5.5-6.0 CONNECTORS. WHEN FOLLOWING UP ON CASE WITH SURGEON, IT WAS STATED THAT THIS IS THE THIRD TIME THIS HAS HAPPENED WITH THE SAME CONNECTORS. THE SALES REP DO NOT HAVE KNOWLEDGE OR PREVIOUS CASES.

    Patient problems: Injury; No Code Available

    MAUDE report 5753183 ↗

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.