MEDOS INTERNATIONAL SÃ RL CH SINGLE-INNER SETSCREW; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
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Model Number 179702000 |
Device Problem
Loose or Intermittent Connection (1371)
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Patient Problem
No Code Available (3191)
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Event Date 01/01/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.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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Event Description
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It was reported that depuy expedium hardware that was implanted in a posterior thoracolumbar fusion on (b)(6) has experienced some hardware loosening.The surgeon, dr.(b)(6), sent a picture of the patient¿s films and pointed out that 3 of the patient¿s set screws have loosened and now the hardware needs to be revised.Patient consequence? yes.Patient consequence description: they¿re going to have to be operated on again to revise the hardware to retighten the set screws.Is the information being submitted for this complaint all the details that are known/available regarding this event? yes.
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Search Alerts/Recalls
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