The product was not received for further information and no information was received on the lot number, expiry date, device storage etc.Foreign body responses or infections may occur with the use of implantable devices, which are known complications.It is included in the manufacturer's instructions for use as a possible adverse event.
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Initial information: the patient showed a major reaction around the median nerve (at the height of the wrist) after 6 weeks.Foreign body giant cell reaction, according to the surgeon caused by vivosorb.Second information (conclusion surgeon): chronic mild active inflammation with a histiocytic reaction, probably due to foreign body material.No other specifics.Final information: patient was treated for a rcurring carpal tunnel syndrome (cts) to prevent new adhesions.Surgeon indicated: it appear to be foreign bidy giant cell reaction.Patient is familiar with several allergies.Outcome patient: the hand is much calmer and the patient is recovering.(this event was already reported, but only the follow-up report had been received).
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