Panta 2 Arthrodesis Nail System PAN-1010-10150Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556828977), received between Nov 9, 2023 and Nov 9, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 9, 2023Break; Break

  IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION SURGERY WITH A LEFT ANKLE PCC FUSION W/INTEGRA IM PANTA NAIL HAD BEEN PERFORMED ON (B)(6) 2022. ON (B)(6) 2023, COMPLAINTS OF PAIN CONTINUED, X-RAY IMAGING APPEARS TO SHOW THE IM NAIL INTACT BUT NO OSSEOUS FUSION ACROSS THE TIBIOTALAR OR SUBTALAR JOINT (NON-UNION) AND A CT SCAN SHOWING SMALL AMOUNT OF LUCENCY ADJACENT TO THE DISTAL PORTION ON THE IM ROD COMPATIBLE WITH MILD LOOSENING WITHOUT OSSEOUS FUSION ACROSS THE TIBIOTALAR OR SUBTALAR JOINT SPACES. ON (B)(6) 2023, ON A TELEMED VISIT, THE PATIENT ADMITS TO PREMATURELY WALKING ON FOOT, DENIES ANKLE PAIN AT THIS TIME BUT SURGEON DISCUSSED CT FINDINGS AND POSSIBLE NEED FOR HW REMOVAL/REVISION AND ADVISED TO REPEAT CT SCAN. ON (B)(6) 2023, X-RAY ANKLE IMAGING REPORT REVEALED AN INTERVAL DEVELOPMENT OF A FRACTURE THROUGH THE IM ROD AT THE LEVEL OF THE TIBIAL METAPHYSIS AS WELL AS INTERVAL DEVELOPMENT OF LUCENCY ALONG THE CALCANEAL SCREWS MEASURING UP TO 1 MM. A SECOND SURGEON DIAGNOSED PAINFUL HW WITH PSEUDOARTHROSIS IN THE LEFT TTC FUSION, A BROKEN IM ROD, METATARSALGIA, LL LIMB. A NEW XRAY SHOWED THE CRACK IN THE NAIL¿ FOR WHICH PATIENT UNDERWENT REVISION ON (B)(6) 2024 WHICH INCLUD

  Patient problems: Arthralgia; Inadequate Osseointegration; Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 18104464 ↗