Product complaint # (b)(4).This report is for an unk - constructs: lcp/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/ investigation.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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.
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Device report from synthes reports an event in south korea as follows: this report is being filed after the review of the following journal article: park, s.J., bae, g.C., and kwon, d.G.(2021), metallosis after using distal fibular locking plate for lateral malleolar fractures: a retrospective study, archives of orthopedic and trauma surgery, vol.Xx, pages 1-7 (south korea).The aim of the current study was to assess metallosis following orif using distal fibular locking plates to treat distal fibular fractures.Between september 2014 and february 2017, a total of 69 patients underwent surgical treatment for lateral malleolar fractures with > 2 mm displacement at the fracture site.These patients were divided into 2 groups.Group a: 38 patients, treated with zplp plate; group b: 31 patients, treated with other plates (16 with the synthes lcp plate and 15 with the je-il arix plate).The mean age was 47.8 years.After 1 year, 69 of 108 patients had undergone surgery to remove the plate and screws.The following complications were reported: 2 patients had wound infections.1 patient had osteomyelitis.2 patients had hypoesthesia.1 patient had peripheral neuropathy.This report is for an unknown synthes lcp.This report is for (1) unk - constructs: lcp.This report is 1 of 1 for (b)(4).
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