Journal of Long-Term Effects of Medical Implants

ISSN for PRINT: 1050-6934

For Online Access

Best Paper Award Selection - Editorial Board Site

2006, Volume16

Issue 2

104 pages

Issue price - $189.00

Christopher A. Radkowski, MD
Division of Orthopaedic Surgery, Duke University Medical Center, Durham, NC, USA

Ryan W. Simovitch, MD
Division of Orthopaedic Surgery, Duke University Medical Center, Durham, NC, USA

Robert D. Zura, MD
Assistant Professor of Orthopaedic Surgery, Duke University Medical Center, Division of Orthopaedic Surgery, Box 3389, Durham, NC 27710, USA

Plate and screw fixation devices are essential in the orthopaedic surgical management of various fractures. Production of these devices has been nearly perfected, with few manufacturing defects reported. Assuming that all implants have been machined properly may cause a surgeon to overlook a manufacturing defect and may potentially result in a poor patient outcome. We report a case of the imperfect manufacturing of a less invasive stabilization system (LISS) plate screw hole. This resulted in a loss of fixation of a single locking screw to the plate in the treatment of a distal femoral fracture. Prompt recognition of the defect helped avoid a potential adverse outcome for the patient. When these issues arise, open dialogue with industry is crucial to promptly identify a solution and enhance patient care. This case highlights the manufacturing company's outstanding quality control and prompt solution of such an occurrence. It is the purpose of this report to raise surgeons' awareness of potential manufacturing problems with implants and prevent negative consequences as a result.

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