VARIAX 614616Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613154969760), received between Dec 23, 2020 and Dec 23, 2020 — classified as 3 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED"; AFTER FRACTURE THE PATIENT WAS TREATED WITH A CLAVICLE PLATE ON (B)(6) 2020, WHICH HAD TO BE REPLACED ON (B)(6) 2020 BECAUSE A SCREW HAD LOOSENED. (THIS REVISION WAS REPORTED SEPARATELY). A LYSIS SEAM AROUND THE SCREWS WAS DIAGNOSED, WHICH CAUSED A LOOSENING. PHONE CALL WITH THE PATIENT ON (B)(6) 2020 REVEALED THE FOLLOWING CLARIFICATIONS: THE PATIENT INITIALLY REACHED OUT TO STRYKER BECAUSE AFTER THE SURGERY THERE WAS NO VISIBLE BONE HEALING. PATIENT ALSO INDICATED THAT AT THE END OF JULY SHE HAD ANOTHER CT SCAN WHICH REVEALED WELL BONE HEALING. ADDITIONAL INFORMATION RECEIVED ON 11/30/2020 WITH PRODUCT DETAILS WHICH CONFIRMED THE DEVICES TO BE STRYKER SCREWS FOR THE PRIMARY AND THE REVISION SURGERY.

  Patient problems: Impaired Healing

  MAUDE report 11069913 ↗
• InjuryDec 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED"; AFTER FRACTURE THE PATIENT WAS TREATED WITH A CLAVICLE PLATE ON (B)(6) 2020, WHICH HAD TO BE REPLACED ON (B)(6) 2020 BECAUSE A SCREW HAD LOOSENED. (THIS REVISION WAS REPORTED SEPARATELY.) A LYSIS SEAM AROUND THE SCREWS WAS DIAGNOSED, WHICH CAUSED A LOOSENING. PHONE CALL WITH THE PATIENT ON (B)(6) 2020 REVEALED THE FOLLOWING CLARIFICATIONS: THE PATIENT INITIALLY REACHED OUT TO STRYKER BECAUSE AFTER THE SURGERY THERE WAS NO VISIBLE BONE HEALING. PATIENT ALSO INDICATED THAT AT THE END OF (B)(6) SHE HAD ANOTHER CT SCAN WHICH REVEALED WELL BONE HEALING. ADDITIONAL INFORMATION RECEIVED ON 11/30/2020 WITH PRODUCT DETAILS WHICH CONFIRMED THE DEVICES TO BE STRYKER SCREWS FOR THE PRIMARY AND THE REVISION SURGERY.

  Patient problems: Impaired Healing

  MAUDE report 11069905 ↗
• InjuryDec 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED"; AFTER FRACTURE THE PATIENT WAS TREATED WITH A CLAVICLE PLATE ON (B)(6) 2020, WHICH HAD TO BE REPLACED ON (B)(6) 2020 BECAUSE A SCREW HAD LOOSENED. (THIS REVISION WAS REPORTED SEPARATELY) A LYSIS SEAM AROUND THE SCREWS WAS DIAGNOSED, WHICH CAUSED A LOOSENING. PHONE CALL WITH THE PATIENT ON (B)(6) 2020 REVEALED THE FOLLOWING CLARIFICATIONS: THE PATIENT INITIALLY REACHED OUT TO STRYKER BECAUSE AFTER THE SURGERY THERE WAS NO VISIBLE BONE HEALING. PATIENT ALSO INDICATED THAT AT THE END OF (B)(6) SHE HAD ANOTHER CT SCAN WHICH REVEALED WELL BONE HEALING. ADDITIONAL INFORMATION RECEIVED ON 11/30/2020 WITH PRODUCT DETAILS WHICH CONFIRMED THE DEVICES TO BE STRYKER SCREWS FOR THE PRIMARY AND THE REVISION SURGERY.

  Patient problems: Impaired Healing

  MAUDE report 11069900 ↗