AXSOS 437103Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613154482092), received between Nov 7, 2022 and Nov 7, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K061012); they may or may not involve this specific model.

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 7, 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 15747525 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K061012. One submission often covers many models, so check the product and lot details in each record.

• Z-1062-2009 · Nov 24, 2008 · Terminated
  AxSOS T8 Screwdriver, 3.0mm Locking Set. REF 702746. This product is non sterile. Distributed in the USA by Howmedica Osteonics Corp, Mahwah, NJ. The screwdrivers of the AxSOS s
• Z-1063-2009 · Nov 24, 2008 · Terminated
  AxSOS Torque Limiting Screwdriver, T8 1.5 Nm 3.0mm Locking Set. REF 702749. This product is non sterile. Distributed in the USA by Howmedica Osteonics Corp, Mahwah, NJ. The torqu