PANGEA 542021SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327614596), received between Jun 30, 2026 and Aug 28, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Fracture” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

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

• InjuryAug 28, 2026Fracture

  As reported: "During a Pangea PH procedure, drilling was performed through the posterior screw hole in the second row from the proximal side. After screw insertion, fluoroscopic/X-ray confirmation revealed that the tip of the drill bit had fractured and remained within the bone.The surgeon determined that removal of the fractured drill bit tip was not feasible and therefore completed the procedure with the fragment left in situ."

  Patient problems: Foreign Body In Patient

  MAUDE report 50500183 ↗
• InjuryJun 30, 2026Fracture

  AS REPORTED: "DURING DRILLING, THE TIP OF THE DRILL BROKE OFF DUE TO INTERFERENCE WITH AN ALREADY INSERTED SCREW, LEAVING ABOUT 2MM INSIDE THE BODY. IT COULD NOT BE REMOVED, SO THE WOUND WAS CLOSED IN THAT STATE."

  Patient problems: Foreign Body In Patient

  MAUDE report 25668249 ↗