NA 212.213Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982152206), received between Sep 10, 2018 and Jul 11, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (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 18, 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.

• InjuryJul 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2023, WHERE SYNTHES STAINLESS STEEL CANNULATED BONE SCREWS WERE USED. DURING THE PROCEDURE A NUMBER OF SYNTHES TRAUMA PRODUCTS WERE IMPLANTED, INCLUDING A HIP PLATE, CORTEX SCREWS AND SIDE SCREWS. POST-SURGERY, THE PATIENT HAS BEEN EXPERIENCING SYMPTOMS THAT LEAD THEM TO BELIEVE THEY MAY BE HAVING AN ALLERGIC REACTION TO THE IMPLANTED ITEMS. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 5.0MM LOCKING SCREW SLF-TPNG WITH T25 STARDRIVE RECESS 38MM. THIS IS REPORT 6 OF 7 FOR (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 17300246 ↗
• InjuryJul 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2023, WHERE SYNTHES STAINLESS STEEL CANNULATED BONE SCREWS WERE USED. DURING THE PROCEDURE A NUMBER OF SYNTHES TRAUMA PRODUCTS WERE IMPLANTED, INCLUDING A HIP PLATE, CORTEX SCREWS AND SIDE SCREWS. POST-SURGERY, THE PATIENT HAS BEEN EXPERIENCING SYMPTOMS THAT LEAD THEM TO BELIEVE THEY MAY BE HAVING AN ALLERGIC REACTION TO THE IMPLANTED ITEMS. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 5.0MM LOCKING SCREW SLF-TPNG WITH T25 STARDRIVE RECESS 38MM. THIS IS REPORT 3 OF 7 FOR (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 17300242 ↗
• InjurySep 10, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2017, PATIENT WAS TREATED WITH DISTAL FEMUR FRACTURE SYSTEM DUE TO COMPLEX FRACTURE. ON (B)(6) 2018, PATIENT SUFFERED PAIN DUE TO A BODY-HEIGHT FALL. MEDICAL IMAGE EXAMINATION ON AN UNKNOWN DATE INDICATED THAT THERE WERE BROKEN SCREWS AS WELL AS A DELAYED CONSOLIDATION OF THE FRACTURE. REVISION SURGERY FOR THE REMOVAL OF IMPLANT AND PLACING OF A NEW ONE IS CURRENTLY UNSCHEDULED. PATIENT REQUESTED A VOLUNTARY DISCHARGE AND CAN NO LONGER BE CONTACTED. CONCOMITANT DEVICES: TRAUMA PLATE (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: UNKNOWN), TRAUMA SCREWS (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: UNKNOWN). THIS REPORT IS FOR A 5.0MM LOCKING SCREW SELF-TAPPING WITH T25 STARDRIVE RECESS 38MM. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Impaired Healing; Pain

  MAUDE report 7861264 ↗