Since this event resulted in the need for medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, it must be presumed that the malfunction would be likely to cause or contribute to a serious injury should it recur.As such, this event meets the definition of a reportable event per 21 cfr part 803.We discovered that the implant library had the surgical axis placement of the implant matched to the restorative/abutment axis, thereby misaligning the actual surgical placement axis.Until this issue has been rectified in our library we will block all orders with these specific angulated implants.We will correct this mistake in our next library release ((b)(6) 2016).
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