NA 214.842Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982154705), received between Mar 18, 2019 and Jul 11, 2023 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 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 SYNTHESE STAINLESS STEEL CANNULATED BONE SCREWS WERE USED. DURING THE PROCEDURE A NUMBER OF SYNTHESE 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 4.5MM CORTEX SCREW SELF-TAPPING 42MM. THIS IS REPORT 2 OF 7 FOR (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 17299997 ↗
• InjuryNov 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT DYNAMIC HIP SYSTEM (DHS). THERE WAS SURGICAL SITE INFECTION POSTOPERATIVE COMPLICATIONS REPORTED. PATIENT STATUS/ OUTCOME? FRACTURE UNITED AFTER REVISION WITH ANTIBIOTIC COATED IMN. THIS REPORT IS FOR ONE (1)4.5MM CORTEX SCREW SELF-TAPPING 42MM. THIS IS REPORT 5 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15801417 ↗
• InjuryNov 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT DYNAMIC HIP SYSTEM (DHS). THERE WAS AVN/OSTEONECROSIS OF THE FEMORAL HEAD POSTOPERATIVE COMPLICATIONS REPORTED. THIS REPORT IS FOR ONE (1) 135 DEG DHS PL-STD BARREL 2 HOLES/46 THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Necrosis

  MAUDE report 15801124 ↗
• InjuryNov 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021. THE PATIENT UNDERWENT FOR A SURGERY. DURING A SURGERY, THERE WAS A REVISION FIXATION DUE TO FRACTURE DISTAL TO HARDWARE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR ONE (1) 4.5MM CORTEX SCREW SELF-TAPPING 42MM. THIS IS REPORT 3 OF 6 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 12788440 ↗
• MalfunctionJul 28, 2021Break; Break

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENTS INVOLVING A TOTAL OF 1 ACTUAL DEVICES FOR BROKEN SCREWS. PATIENT¿S DEMOGRAPHICS WERE PROVIDED FOR SOME OF THE EVENTS AS FOLLOWS: PATIENT¿S AGE RANGE (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12242596 ↗
• InjuryMay 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, PATIENT UNDERWENT A HARDWARE REMOVAL PROCEDURE DUE TO BONE HEALING. THE DOCTOR SCHEDULED A REMOVAL OF AN ANGLED BLADE PLATE AND THE PATIENT HAD A PROXIMAL FEMUR CORRECTION ON A PREVIOUS DATE. PATIENT WAS HEALED AND NO LONGER NEEDED THE IMPLANTED HARDWARE. REMOVAL WAS VERY UNEVENTFUL AND HAD NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 4.5MM CORTEX SCREW SELF-TAPPING 42MM. THIS IS REPORT 4 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11837607 ↗
• MalfunctionMar 18, 2019Break; Break

  THIS REPORT IS AGAINST MAUDE REPORT MEDWATCH NUMBER MW5083617. THE ONLY INFORMATION CONTAINED IN THIS REPORT IS CORRECTION OR ADDITIONAL INFORMATION. CONCOMITANT DEVICE REPORTED: UNK - SCREWS: TRAUMA (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # UNKNOWN). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8430283 ↗