Pangea 04.620.000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034742311), received between Sep 25, 2019 and Sep 26, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Migration” (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 18, 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.

• InjurySep 26, 2019Migration; Migration

  ITS HARD TO SAY WHETHER IT¿S THE SET OF SCREW OR THE SCREW ITSELF. THEY WORK IN SYN WITH EACH OTHER IN THE CONSTRUCT.

  Patient problems: No Code Available

  MAUDE report 9125083 ↗
• InjurySep 25, 2019Migration; Migration

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2019. THE INNER PANGEA SET SCREW HAD BACKED OUT ON ITS OWN AND ALLOWED THE ROD TO SLIDE CAUDALLY. ORIGINAL IMPLANTATION OF THE DEVICES HAD OCCURRED APPROXIMATELY FOUR YEARS PRIOR. PATIENT WAS REVISED TO EXP 5.5 POLY SCREW. THERE WERE NO ISSUES DURING THE REVISION PROCEDURE, AND NO SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICES: ROD (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: UNKNOWN). THIS REPORT IS FOR A TITANIUM (TI) PANGEA(TM) LOCKING CAP. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9120392 ↗