(b)(4).Per the facility, all of the removed product was discarded and is not available for evaluation.The investigation could not be completed; no conclusion could be drawn as no product was received.Device history review: manufacturing date: february 15, 2006 ¿ expiration date: december 31, 2007.(b)(4).No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.Device used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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It was reported that a revision of a cranioplasty was performed on (b)(6) 2015.The patient underwent an original procedure due to fibrous dysplasia on (b)(6) 2005.Approximately one (1) year ago, the patient complained of loose fragments moving around.Computerized tomography (ct) scan done on an unknown date showed broken pieces of (b)(4) crs.The revision procedure revealed that the superficial portion of the (b)(4) crs had crumbled and broken (approximately 10%) while the portion underneath remained intact.The surgeon opted to remove all of the (b)(4) and replace with a custom, cranial implant.The revision procedure was completed successfully without incident.There were no surgical delays and no additional medical intervention required.This report is 1 of 2 for (b)(4).
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