The reported could not be confirmed since the device was not returned for evaluation and no other evidences were provided.A device inspection was not possible since the affected device was not returned, and no other evidences were provided for investigation.More detailed information about the complaint event such as operative reports, x-rays, patient details, as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.The instruction for use was reviewed: 6adverse effects: conditions attributable to non-union, osteoporosis, osteomalicia, diabetes, inhibited revascularization and poor bone formation can cause loosening, bending, cracking, fracture of the device or premature loss of rigid fixation with the bone.Improper alignment can cause a mal-union of the bone and/or bending, cracking or even breakage of the device.¿ if the device is returned or if any additional information is provided, the investigation will be reassessed.
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