OBERDORF SYNTHES PRODUKTIONS GMBH UNK - NAIL HEAD ELEMENTS: PFNA-II BLADE; ROD, FIXATION, INTRAMEDULLARY
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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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510k: this report is for an unk - nail head elements: pfna-ii blade/unknown lot.Part and lot numbers are unknown; udi number is unknown.Ocupation: synthes employee 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 product was received; no conclusion could be drawn at the time of filing this report.(b)(4).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 (b)(6) as follows: it was reported that in (b)(6) 2018, the patient underwent an implant surgery for femoral sub-trochanteric fracture with the pfna and the nail was break on (b)(6) 2019.The hospital followed up the patient without any removal surgery, but the fracture part didn¿t unite.In (b)(6) 2019, the nail broke at the fracture part due to non-union.The day after that, the patient underwent re-operation, and the re-operation was completed successfully.The fracture was atypical fracture, and it caused non-union and the breakage of the nail.This is report 1 of 3 for (b)(4).Related product complaints: (b)(4).
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Search Alerts/Recalls
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