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Device Problem
Device Slipped (1584)
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Patient Problems
Bone Fracture(s) (1870); Unspecified Infection (1930); Pain (1994)
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Event Date 11/01/2018 |
Event Type
Injury
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: 510k: this report is for an unk - plates: t-locking plates 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.Product was not returned.Based on the information available, it has been determined that no corrective and/or 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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Event Description
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Device report from synthes reports an event in china as follows: this report is being filed after the review of the following journal article: wang j., et al (2018) oblique t-shaped titanium plate combined with kirschner wire fixation in the treatment of type c fracture of the distal radius, chinese journal of orthopaedic surgery vol.26, no.22, pages 1-8 (china) this study aims to investigate clinical outcomes of volar oblique t-shaped locked titanium plate combined with kirschner wire for ao type c distal radius fracture in the elderly.From june 2014 to june 2017, a total of 100 elderly patients with type c fracture of the distal radius were admitted.They were randomly divided into locking plate group, (50 cases) 27 males and 23 females, aged 67 ~ 78 years, with a mean one of (71.31 ± 8.23) years and a common plate group (50 cases) there were 26 males and 24 females, aged 69 ~ 82 years, with mean one of (71.92 ± 10.19) years.The locked group had the fracture fixed with a volar oblique t-shape locked titanium plate combined with kirschner wire while the non-locked group received a conventional plate and kirschner wire.The internal fixation device used for the patient was provided by johnson & johnson.All patients were followed up for 10-15 months, with an average of (12.34 ± 2.61) months.Reported complications: there were 5 cases of locking plate with superficial incision infection.The infection was controlled after dressing change and treatment, and the incision healed.Long-term complications: 2 patients in the locking plate group had internal fixation loosening and fracture displacement and were given second revision surgery, with good postoperative recovery at follow-up, 5 patients had mild pain during activity and were asymptomatic at rest.There were 4 cases of the common plate with superficial incision infection.The infection was controlled after dressing change and treatment, and the incision healed.Long-term complications: 1 patient in the common plate group had internal fixation loosening and fracture displacement and was given second revision surgery, with good postoperative recovery.This report is for unknown synthes volar oblique t-locking titanium plate, unknown synthes conventional plate and unknown synthes kirschner wire.This is report 1 of 5 for complaint (b)(4).
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Search Alerts/Recalls
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