VARIAX 628030SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04546540686923), received between Sep 18, 2019 and Nov 7, 2022 — classified as 4 injuries.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 7, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE PLATE BROKE OFF WHICH RESULTED IN A REVISION SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 15744972 ↗
• InjuryApr 2, 2021Fracture; Fracture

  IT WAS REPORTED THAT "ON (B)(6) 2020, THE PATIENT UNDERWENT IMPLANTATION OF THE SUBJECT PLATE DUE TO CLAVICLE FRACTURE (RIGHT). ON UNKNOWN DATE, THE PATIENT COMPLAINED OF PAIN WHICH REVEALED BROKE OF PLATE IN X-RAYS. ON (B)(6) 2021, REVISION OF PLATE WAS PERFORMED. THE PATIENT WAS SUSPECTED OF NONUNION."

  Patient problems: Failure of Implant; Implant Pain; Nonunion/Delayed-union Bone Fracture

  MAUDE report 11609302 ↗
• InjurySep 18, 2019Break

  ON (B)(6) 2018: A (B)(6) YEARS OLD WOMAN CAME IN WITH A MULTI TRAUMA. SOME RIBS, THE STERNUM AND THE RIGHT CLAVICLE WERE BROKEN. THE CLAVICLE WAS CONSERVATIVELY TREATED BECAUSE SHE WAS A HEAVY SMOKER. NO SURGERY. ON (B)(6) 2018: A PSEUDO ARTHROSIS HAD DEVELOPED IN THE RIGHT CLAVICLE, THIS WAS CLEARED AND A VARIAX CLAVICLE 10 HOLES PLATE WAS PLACED IN COMBINATION WITH CERASORB AND BONE MARROW WHICH WAS HARVESTED VIA A PUNCTION. ON (B)(6) 2018: THE RIGHT CLAVICLE WAS NOT CONSOLIDATED. BONE MARROW FROM THE ILIAC CREST WAS HARVESTED AND PUT IN PLACE AFTER PLACING A NEW VARIAX CLAVICLE 10 HOLES PLATE (THIS INCIDENT). ON (B)(6) 2019: AGAIN NO CONSOLIDATION SHOWED. A NEW OPERATION WAS NECESSARY. THIS TIME A BONE CHIP FROM THE ILIAC CREST WAS PLACED TOGETHER WITH A NEW VARIAX CLAVICLE 10 HOLES PLATE (LATER INCIDENT). ON (B)(6) 2019: THE PATIENT CAME IN BECAUSE SHE EXPERIENCED THAT THE PLATE MUST HAVE BEEN BROKEN. AN X-RAY CONFIRMED THAT. ON (B)(6) 2019: THE PATIENT WAS OPERATED AGAIN. THIS SHE GOT TWO PLATES. ONE VARIAX SUPERIOR CLAVICLE 10 HOLES PLATE AND ONE VARIAX 8 HOLES ANTERIOR PLATE (LATER INCIDENT).

  Patient problems: Failure of Implant

  MAUDE report 9085078 ↗
• InjurySep 18, 2019Break

  ON (B)(6) 2018: A (B)(6) YEARS OLD WOMAN CAME IN WITH A MULTI TRAUMA. SOME RIBS, THE STERNUM AND THE RIGHT CLAVICLE WERE BROKEN. THE CLAVICLE WAS CONSERVATIVELY TREATED BECAUSE SHE WAS A HEAVY SMOKER. NO SURGERY. ON (B)(6) 2018: A PSEUDO ARTHROSIS HAD DEVELOPED IN THE RIGHT CLAVICLE, THIS WAS CLEARED AND A VARIAX CLAVICLE 10 HOLES PLATE WAS PLACED IN COMBINATION WITH CERASORB AND BONE MARROW WHICH WAS HARVESTED VIA A PUNCTION. ON (B)(6) 2018: THE RIGHT CLAVICLE WAS NOT CONSOLIDATED. BONE MARROW FROM THE ILIAC CREST WAS HARVESTED AND PUT IN PLACE AFTER PLACING A NEW VARIAX CLAVICLE 10 HOLES PLATE (PREVIOUS INCIDENT). (B)(6) 2019: AGAIN NO CONSOLIDATION SHOWED. A NEW OPERATION WAS NECESSARY. THIS TIME A BONE CHIP FROM THE ILIAC CREST WAS PLACED TOGETHER WITH A NEW VARIAX CLAVICLE 10 HOLES PLATE (THIS INCIDENT). ON (B)(6) 2019: THE PATIENT CAME IN BECAUSE SHE EXPERIENCED THAT THE PLATE MUST HAVE BEEN BROKEN. AN X-RAY CONFIRMED THAT. ON (B)(6) 2019: THE PATIENT WAS OPERATED AGAIN. THIS SHE GOT TWO PLATES. ONE VARIAX SUPERIOR CLAVICLE 10 HOLES PLATE AND ONE VARIAX 8 HOLES ANTERIOR PLATE (LATER INCIDENT).

  Patient problems: Failure of Implant

  MAUDE report 9085077 ↗