NA 241.623Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982167408), received between Mar 2, 2018 and Aug 4, 2023 — classified as 2 injuries.

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 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 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT# (B)(6). DIABETES MELLITUS: NO. INDEX SURGERY OR REVISION SURGERY? INDEX. DID A POST-OPERATIVE COMPLICATION OCCUR? YES. DESCRIBE POST-OPERATIVE COMPLICATION(S): NON-UNION. COMMENTS/NOTES: NON-UNION SECONDARY TO FRACTURE PATTERN/COMMINUTION AND BONE LOSS. UNION AT (B)(6) WEEKS WITH NEW FIXATION. THIS REPORT IS FOR A LOCKING CALCANEAL PLATE SHORT-LEFT. THIS IS REPORT 1 OF 10 FOR PC (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 17458989 ↗
• InjuryMar 2, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT FELL OFF OF THE TOP OF A HOUSE FROM THE LADDER FALLING. PATIENT JUMPED OFF RATHER THAN GO THROUGH THE WINDOW, HIT THE LEFT HEEL BONE ON A CONCRETE SLAB AND SHATTERED THE HEEL OF THE BONE. X-RAYS SHOWED A COMMINUTED FRACTURE OF THE OS CALCIS WITH CENTRAL DEPRESSION AND MEDIAL DISPLACEMENT OF THE POSTERIOR HEEL. THE SKIN WAS INTACT BUT MARKEDLY SWOLLEN. THE PATIENT WAS TREATED WITH COMPRESSION DRESSING AND THE SKIN MONITORED ON (B)(6) 2008. ONCE THE SWELLING WAS DOWN AND THE TISSUES APPEARED TO BE STABLE, PATIENT WAS BROUGHT IN FOR SURGERY ABOUT TWO (2) WEEKS LATER. PATIENT UNDERWENT ORIF (OPEN REDUCTION INTERNAL FIXATION) WITH AO LOCKING OS CALCIS PLATE AND SCREWS ON (B)(6) 2008. THE FRACTURES WERE IMPACTED AND HAD EARLY HEALING, AND NEEDED TO BE TRACED OUT. FRACTURE LINES WERE GRADUALLY MOBILIZED, PARTICULARLY THE POSTERIOR HEEL COMPONENT WAS MOBILIZED. A SOFT TISSUE RELEASE ON THE MEDIAL SIDE USING JUST A PRESSURE OF A MODERATELY BLUNT OSTEOTOME WAS USED TO HELP RELEASE THE MEDIAL STRUCTURES UNTIL THE POSTERIOR HEEL WAS MOBILIZED. BOHLER¿S ANGLE COULD THEN BE CORRECTED AND THE ALIGNMENT OF THE POSTERIOR HEEL CORRECTED. THE SMALL THIN LATERAL CORTEX F

  Patient problems: No Code Available; Pain

  MAUDE report 7311015 ↗