This complaint has been reported during a literature review performed by the post market surveillance group.The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information is available.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.The device history record could not be reviewed because the affected lot number was not communicated.If any further information is provided, the investigation report will be updated.Device disposition is unknown.
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The manufacturer became aware of study from (b)(6).The title of this report is ¿clavicle lengthening by distraction osteogenesis for congenital clavicular hypoplasia: case series and description of technique¿ which is associated with the stryker ¿hoffman ii external fixator¿ system.Within that publication, post-operative complications/ adverse events were reported, which occurred from 2006 to 2011.It was not possible to ascertain specific device details from the report, 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 6 complaints were initiated retrospectively for adverse events mentioned in the report.This product inquiry addresses atrophic regenerate followed by revision.The report states: ¿one of these patients (patient 1) subsequently developed an atrophic regenerate that required stimulation with a bone graft substitute with osteoinductive properties and redistribution of local bone to stimulate union.This patient subsequently had a contralateral clavicle lengthened at 0.75mm/d and formed consolidated regenerate that did not require internal fixation after removal of the external fixator.".
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