OBERDORF SYNTHES PRODUKTIONS GMBH 2.7MM TI CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 16MM; PLATE,FIXATION,BONE
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Model Number 402.876 |
Device Problem
Off-Label Use (1494)
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Patient Problems
Injury (2348); No Code Available (3191)
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Event Date 09/01/2020 |
Event Type
Injury
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Manufacturer Narrative
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Additional procode: hwc.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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 (b)(6) as follows: it was reported that on (b)(6) 2020 during an open reduction fibula and tibia procedure, the surgeon implanted lateral distal fibular plates and used 2.7mm cortical screws in the body of the plate instead of the indicated 3.5mm screws.After a previous procedure, the surgeon directed the staff to retain 3.5mm screws and they were sent to be sterilized.The surgeon began the patient's procedure without the 3.5mm being available as they were still being sterilized.After being advised that using the 2.7mm cortical screws could generated complications in the patient, the surgeon proceeded to implant the 2.7mm cortical screws.There is no further information available.This report is for one (1) 2.7mm ti cortex screw slf-tpng with t8 stardrive recess 16mm.This is report 3 of 10 for (b)(4).
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