FDA Adverse Event Injury Summary report: N

OSTEOFIL RTI ICM MOLDABLE PASTE

MDR report key: 3315634 · Received August 20, 2013

Report

Report Number: 3002719998-2013-00052
Event Type: Injury
Date Received: August 20, 2013
Date of Event: July 5, 2013
Report Date: July 18, 2013
Manufacturer: RTI SURGICAL, INC
Product Code: MQV
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

INVESTIGATION: DONOR RECORDS RE-REVIEW INDICATES THE DONOR WAS FREE OF SIGNS, SYMPTOMS AND BEHAVIORS ASSOCIATED WITH SYSTEMIC INFECTIOUS DISEASES AND MET ALL RTI ELIGIBILITY REQUIREMENTS. NO DEVIATIONS WERE NOTED DURING MANUFACTURING RECORDS RE-REVIEW. THE ALLOGRAFT UNDERWENT CANCELLE SP, A VALIDATED BONE MATRIX STERILIZATION PROCESS THAT INACTIVATES POTENTIAL PATHOGENS THROUGH A COMBINATION OF CHEMICAL TREATMENTS AND GAMMA IRRADIATION. NO RELATED COMPLAINTS HAVE BEEN REPORTED TO RTI FOR DISTRIBUTED ALLOGRAFTS FROM THIS DONOR. RESULTS OF INVESTIGATION: GRAFT ID# (B)(4) MET ALL RTI SPECIFICATIONS AND RELEASE CRITERIA AT THE TIME OF DISTRIBUTION. CONCLUSION: TO DATE, RTI'S INVESTIGATION IS WITHOUT INDICATION THAT THE GRAFT CONTRIBUTED TO COMMUNICABLE DISEASE TRANSMISSION.

Description of Event or Problem · 1

RTI SURGICAL, INC. (RTI) WAS INFORMED THAT A PT UNDERWENT LUMBAR REVISION SURGERY WHERE AN RTI OSTEOFIL PASTE ALLOGRAFT WAS IMPLANTED (DATE NOT PROVIDED) AND A FISTULA FORMED POSTOPERATIVELY. DURING AN ADDITIONAL SURGICAL EVENT PERFORMED ON (B)(6) 2013, THE PASTE ALLOGRAFT APPEARED YELLOWISH AND WAS REMOVED. SPECIMENS (UNIDENTIFIED) OBTAINED ON (B)(6) 2013, WERE VERBALLY REPORTED TO BE POSITIVE FOR MICROORGANISM GROWTH. THE PT IS REPORTEDLY RECOVERY WELL AND THE WOUND IS HEALING.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
404223	OSTEOFIL RTI ICM MOLDABLE PASTE	NONE	MQV	RTI SURGICAL, INC		101081070

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention