Device used for treatment, not for diagnosis.
This report is for an unknown pfna ii system (unknown quantity/unknown lot).
The investigation could not be completed; no conclusion could be drawn, as no device was returned and no lot number or part number was provided.
(b)(4).
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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This report is being filed after subsequent review of the following literature article: cho, w; et al (2016) provisional pin fixation can maintain reduction in a3 intertrochanteric fractures.
Arch orthop trauma surg, 136:945-955.
This retrospective study introduces a modified provisional guide pin fixation technique and analyze the factors affecting intraoperative reduction loss, especially in comparison between two methods.
Between july 2013 and june 2015, 11 patients received provisional guide pin fixation-assisted cephalomedullary nailing (pfna ii, depuy synthes, usa) for ao/ota 31 a3 intertrochanteric fractures.
Mean patient age was 73 years (range 58¿82 years).
The aim of provisional pin fixation is temporary maintenance of reduction stability between main fragments using a single threaded guide pin without the interferences of nailing procedures.
Following provisional pin fixation, instruments used for the percutaneous reduction were released and could be removed from the fracture site such that the provisional pin alone was enough to maintain reduction during intramedullary nail insertion.
One case of reduction loss was observed when the nail was inserted after provisional pin fixation.
In this case, reduction was restored with addition of supplementary percutaneous reduction instruments.
All patients were permitted to follow routine rehabilitation protocols in our hospital including standing exercises 2 days after surgery, and walking training with a crutch or walker 3 days after surgery.
This report is 1 of 1 for (b)(4).
This report is for an unknown pfna ii system and refers to the serious injury of case 1, (b)(6) male patient who experienced a loss of reduction.
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