MEDPOR 5444-0-310Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613252457640), received between Nov 26, 2019 and Jun 2, 2026 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2026Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE SURGEON SAW A GAP AND WAS NOT SATISFIED WITH THE IMPLANT FIT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25359785 ↗
• InjuryMay 22, 2024Fracture; Inadequacy of Device Shape and/or Size; Fracture; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED BY THE STRYKER REPRESENTATIVE THAT THE SURGEON WAS HAVING PROBLEMS WITH IMPLANTING THE DEVICE. THIS RESULTED IN A DELAY IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19375571 ↗
• InjuryDec 21, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD A BUMP NEAR WHERE HIS GLASSES SIT. THE SURGEON HAD A CT SCAN DONE THAT SHOWED THE RIGID FIXATION COMING OFF OF THE BONE. THERE WAS MEDICAL INTERVENTION REQUIRING A REVISION SURGERY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cerebral Edema

  MAUDE report 13052593 ↗
• InjuryDec 20, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD MOST ANTERIOR FIXATION AS WELL AS MOST POSTERIOR FIXATION PULLING OUT FROM PATIENT¿S BONE. THE SURGEON STATED THAT THIS WAS POSSIBLY DUE TO PRESSURE FROM BRAIN SWELLING.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cerebral Edema

  MAUDE report 13047820 ↗
• InjuryDec 20, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PATIENT HAD A NEW MEDPOR IMPLANTED ON (B)(6) 2020 DUE TO DISPLACEMENT ISSUES WITH THE ORIGINAL IMPLANT AFTER BRAIN SWELLING.

  Patient problems: Swelling/ Edema

  MAUDE report 13047717 ↗
• InjuryNov 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PLATE WAS REMOVED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 9375806 ↗