AXSOS 371526Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613154864157), received between Nov 21, 2022 and Nov 21, 2022 — classified as 1 injury.

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

• InjuryNov 21, 2022Device Appears to Trigger Rejection; Inaccurate Information; Device Appears to Trigger Rejection; Inaccurate Information

  IT WAS REPORTED THAT THE PATIENT BROKE HER LEFT SHOULDER AND HAD PLATE PUT IN HER ARM. SHE HAD A REACTION TO THE PLATE AND THE PLATE WAS REMOVED. PAPER IN BOX WITH PLATING SYSTEM HAD DIFFERENT INFORMATION THAN WHAT WAS DOCUMENTED ONLINE. THE PATIENT WANTS MORE INFORMATION ON THE BLOOD TEST THAT WAS SUPPOSED TO BE CONDUCTED BEFORE THE PATIENT WAS IMPLANTED WITH THE STRYKER PLATE. THE PATIENT ALLEGES THAT THE SURGEON NEVER DID THE BLOOD TEST. 3 MONTHS AFTER THE PLATE WAS IMPLANTED THE PATIENT EXPERIENCE A SEVERE REACTION WITH IMMENSE SWELLING AND PAIN. PATIENT SAID THE SURGEON TOLD HER THAT THE REACTION WAS IN HER HEAD. PATIENT STATES THAT SHE WAS "TOXIC" DUE TO THE NICKLE THAT WAS BEING EMITTED FROM THE STAINLESS STEEL MATERIAL THE PLATE WAS MADE OF. PATIENT ALLEGES THAT IF THE SURGEON HAD CONDUCTED THE REQUIRED BLOOD WORK PRIOR TO THE SURGERY, THIS ISSUE COULD HAVE BEEN MITIGATED BY THE USE OF A TITANIUM PLATE INSTEAD. THE PATIENT MENTIONED SHE IS WORKING WITH HER ATTORNEY ON A CASE AGAINST THE SURGEON AND THE HOSPITAL AND MENTIONED THAT SHE ALSO FELT STRYKER HAD SOME LIABILITY IN THIS AS WELL.

  Patient problems: Implant Pain; Swelling/ Edema

  MAUDE report 15833973 ↗