Baxter medical assessment: this is a single case report of a patient entered into research protocol (b)(4).
Inductigraft was used during an l4 - s1 bilateral fusion.
At 48 hours post op, the patient demonstrated signs of abdominal pain and tenderness (psoas inflammation, peritonism query appendicitis).
The patient underwent exploratory laparotomy which was negative.
It is unlikely the use of inductigraft caused or contributed to the patient's symptoms which are more likely related to the surgical procedure or patient positioning during the spinal procedure.
Baxter follow-up medical assessment: the additional information received does not allow additional clinical conclusion.
The implantation of inductigraft (a 0.
8% silicated calcium phosphate bone graft substitute) in a posterolateral fusion, in the paravertebral lumbar area is both anatomically and functionally not able to induce a peritonitic or retroperitoneal (inflammatory?) reaction.
The reported serious adverse event is not related to the use of inductigraft.
Baxter follow-up medical assessment: this is one of two cases of posterior lumbar lateral fusion in which inductigraft has been used (two of five cases of this investigator).
Based on the follow-up information regarding this second case it became obvious that the major symptoms were related to the psoas (retroperitoneal inflammation), and not as initially suspected a peritoneal reaction.
Although other alternative surgery-, and /or pathology-related causes must be taken into account, one cannot exclude that inductigraft has caused or contributed to the local inflammatory reaction.
Upon review of the batch record for this product lot a follow-up report will be submitted.