The index surgery was reported to have occurred in (b)(6) 2014.The patient reported that following the anaphylaxis event (details unknown).The construct was reported to have been altered to remove the cobalt-chromium rods and replaced with titanium rods.The date of this revision is unknown.Following this, a request for peek material samples was received from the patient.A peek sample was provided to the patient on (b)(6) 2015 to facilitate determination of sensitivity to the peek material.No device has been returned for evaluation.No radiographs have been provided.No sensitivity testing results have been received.The root cause of this reported event has not been determined.Biocompatibility of the peek material has been assessed in accordance with iso 10993 requirements.Labeling review: ".Contraindications: contraindications include, but are not limited to: infection, local to the operative site.Signs of local inflammation.Patients with known sensitivity to the materials implanted." ".Potential risks identified with the use of this system, which may require additional surgery, include:.Metal sensitivity or allergic reaction to a foreign body".".Caution must be taken due to potential patient sensitivity to materials.Do not implant in patients with known or suspected sensitivity to the aforementioned materials.Exercise caution when choosing implant sizes, as larger implants may not be suitable".Device not returned.
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