|Catalog Number 506005078082|
|Event Date 06/09/2012|
The following is a report of an adverse event received from (b)(4) on (b)(4) 2012 regarding study protocol # (b)(4).
The report refers to subject (b)(6) ((b)(6); gender: female).
Reported ae term(s): psoas inflammation / symptoms of peritonism / appendicitis.
At 48 hours post-op (l4-5, bilateral fusion), the patient developed r.
F pain and tenderness.
Mri nad (no appreciable disease), ct showed inflammatory change in dt (right) psoas.
Possible appendicitis, but patient had negative laparoscopy.
Currently treating with abx (antibiotics) iv & analgesia, (possible) reaction to inductigraft implant.
General surgeons performed laparoscopy, which had negative findings.
Clarification received on (b)(4) 2012 with the following information: r.
F means right iliac fossa.
Ct showed inflammatory change in dt (right) psoas gas shadows.
This is a very similar clinical event to subject (b)(6) (reported on 03-may-2012).
The patient's symptoms have now completely resolved (at the time of initial reporting, it was resolved with residual symptoms).
Concomitant medication taken at time of ae: paracetamol 1 g po qds, 1/6 pain, codeine 60 mg po qds, 8/6 pain, laxido given one sachet twice daily, senna 2 tablets once daily, constipation.
Therapy to treat the ae: cefluroxime 750 mg tds and metronidazole 500 mg tds for prophylaxis of infection (no infection identified).
Additional information received from the physician on 26-jul-2012 stating as this has now occurred on 2 occasions in a very similar fashion out of 5 enrolled patients in the trial and never before in the physicians? other fusion patients, per the physician this seems to be too unusual to be just a 'coincidence'.
The physician is therefore concerned that this clinical picture of 'psoas inflammation' is related to the implanted device, which is implanted next to psoas.
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.
The manufacturing facility, baxter (b)(4), completed the investigation.
A review of the batch record for this product lot indicated that all release/testing specifications was met.
The review showed no non-conformities, failures, rework or deviations that are related to the reported event.
This is the first complaint of this nature received for this product lot.
It will be kept on file for trending purposes.