This complaint has been reported during a literature review performed by the post market surveillance group.No product identification is possible.Based on the investigation results, no definitive relation could be established between the product and the reported failure adverse consequence.The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information will be provided.If further relevant information becomes available, the investigation will be reevaluated and resubmitted accordingly.Device evaluated by mfr: device disposition is unknown.
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The manufacturer became aware of a study from university hospital (b)(6).The title of this report is ¿ultrasonically assisted anchoring of biodegradable implants for chevron osteotomies ¿ clinical evaluation of a novel fixation method¿ and is associated with the stryker sonicpin.Within that publication, post-operative complications/ adverse events were reported which occurred between may 5th to september 11th, 2008.It was not possible to ascertain specific device or patient information from the article; a review of the complaint handling database, however, revealed that the events have not been reported by the hospital or by the author of the publication.Therefore, 3 complaints were initiated retrospectively for different adverse events mentioned in the study.This product inquiry addresses fragment dislocation of 2mm on conventional radiographs, possibly due to instability of the pin.The study reports, "at three months follow-up, one patient (3.3%) showed fragment dislocation of 2mm on conventional radiographs, possibly due to instability of the pin.The mri after three months showed no signs of foreign body reactions.At 12 months follow-up, the same patient showed fracture of the pin with complete bone healing without clinical problems.".
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