Device was 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.Catalog number, serial number and lot number are unknown.The device serial or lot number was unknown; therefore, udi: unknown.510(k) number is unknown.The manufacturing site name and address are unknown.Device manufacture date is unknown.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.
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The literature article entitled, "pulsed electromagnetic field therapy improves osseous consolidation after high tibial osteotomy in elderly patients¿a randomized, placebo-controlled, double-blind trial" written by patrick ziegler, andreas k.Nussler, benjamin wilbrand, karsten falldorf, fabian springer, anne-kristin fentz, georg eschenburg, andreas ziegler, ulrich stockle, elke maurer, atesch ateschrang, steffen schroter and sabrina ehnert.The article's purpose was to study how extremely low-frequency pulsed electromagnetic field (elf-pemf) therapy is proposed to support bone healing after injuries and surgical procedures, being of special interest for elderly patients.The study aimed at investigating the effect of specific elf-pemf, recently identified to support osteoblast function in vitro, on bone healing after high tibial osteotomy (hto).The article reported that two unknown patients (one from each group) w/an unknown depuy synthes battery powered handpiece device, experienced post operative infections requiring additional intervention.Depuy product involved: unknown battery power handpiece (trs) device.Adverse event: post operative infection requiring additional intervention.
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