T2 1846-1134SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613153316619), received between Aug 13, 2018 and Sep 24, 2020 — classified as 2 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 18, 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.

• InjurySep 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  "A CT SCAN OF THE PELVIS SUBSEQUENTLY REVEALED AN INTRA-ARTICULAR COXO-FEMORAL SCREW ON THE RIGHT LEG. LAG SCREW WAS REVISED THE (B)(6) 2020." CLARIFICATION RECEIVED: "INSTALLED ON 19/07/2020 : T2 FEMUR CLOU RECON 11X320MM GH REFERENCE : 1846-1134S LOT : K037023. FOLLOWING AN INFECTION OF THE OSTEOSYNTHESIS MATERIAL LEFT LEG NAIL WITH STAPHYLOCOCCUS EPIDERMITIS AND ACINETOBACTER BAUMANNII, CHANGE OF THE MATERIAL. INSTALLED ON (B)(6) 2020 : T2 FEMUR CLOU RECON 11X320MM GH REFERENCE : (B)(4) LOT : K880065RA (CURRENTLY IMPLANTED)".

  Patient problems: Bacterial Infection

  MAUDE report 10583570 ↗
• InjuryAug 13, 2018Appropriate Device Problem Term/Code Not Available

  THE MANUFACTURER BECAME AWARE OF ADVERSE EVENTS FROM THE (B)(6) HIP FRACTURE REGISTER. THE TITLE OF THIS REPORT IS ¿T2 RECON IN THE (B)(6) HIP FRACTURE REGISTER¿ WHICH IS ASSOCIATED WITH THE T2 RECON NAILING SYSTEM, WITHIN THAT REPORT, POST-OPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED, WHICH OCCURRED BETWEEN 2009 AND 2017. A REVIEW OF THE COMPLAINT HANDLING DATABASE REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED PREVIOUSLY TO STRYKER, THEREFORE 13 EVENTS WERE INITIATED RETROSPECTIVELY FOR DIFFERENT ADVERSE EVENTS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES REVISION SURGERY DUE TO DEEP INFECTION. THE PATIENT RECEIVED A DRAINAGE. IT WAS ALSO INDICATED THAT PATIENT PASSED AWAY WITHIN 60 DAYS SINCE THE REVISION SURGERY HOWEVER THE CAUSE AND THE DATE OF THE DEATH WILL NOT BE DISCLOSED.

  Patient problems: Death; Unspecified Infection

  MAUDE report 7777591 ↗