• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER APATECH LTD INDUCTIGRAFT FILLER, BONE VOID, CALCIUM COMPOUND

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BAXTER APATECH LTD INDUCTIGRAFT FILLER, BONE VOID, CALCIUM COMPOUND Back to Search Results
Catalog Number 506005078082
Event Date 06/09/2012
Event Type  Injury  
Manufacturer Narrative

(b)(4). 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.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameINDUCTIGRAFT
Type of DeviceFILLER, BONE VOID, CALCIUM COMPOUND
Manufacturer (Section D)
BAXTER APATECH LTD
370 centennial ave
hertfordshire
UNITED KINGDOM
Manufacturer (Section G)
BAXTER APATECH LTD
370 centennial ave
hertfordshire
UNITED KINGDOM
Manufacturer Contact
joshua leach
one baxter way
westlake village , CA 91362
8053723250
MDR Report Key2676392
Report Number3004450973-2012-00014
Device Sequence Number1
Product CodeMQV
Report Source Manufacturer
Source Type Foreign,Study
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 06/12/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/31/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Physician
Device Catalogue Number506005078082
Device LOT NumberELN83F0461MP
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received08/10/2012
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/31/2012 Patient Sequence Number: 1
-
-