Patient age, dob & weight not provided for reporting.(b)(4).Device is an instrument and is not implanted/explanted.Device is not expected to be returned for manufacturer review/investigation.(b)(4).Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was not returned and no lot number was provided.Based on the information available, 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.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 on an event in (b)(6) as follows: it was reported that the reported devices were used in the surgery on (b)(6) 2017.After the plate was fixed by screws, the surgeon forgot to remove the guiding block and completed the surgery.This was found by the post-operative x-ray images, and the removal surgery was performed under full anesthesia on the same day.The surgeon commented that this happened due to a human error.This complaint involves 1 part.Concomitant device: 1x 441.901s / lot unk (philos 3.5 3ho ti).This report is 1 of 1 for (b)(4).
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