MAUDE Adverse Event Report: OSTEOTECH, INC (SUBSIDIARY OF MEDTRONIC) GRAFTON DBM; FILLER, BONE VOID, OSTEOINDUCTION (W/O HUMAN GROWTH FACTOR)

Model Number NOT REPORTED

Device Problem Insufficient Information (3190)

Patient Problems Erythema (1840); Unspecified Infection (1930); Swelling (2091)

Event Type  Injury  

Event Description

The initial reporter called the manufacturer and reported that she had allograft bone void filler implanted in a tibial non-union fracture in 1994, and reported that ¿every year or so¿ (for the past 20 years) she gets an "infection" (red and slightly swollen) at her incision.She ¿thinks it is the (bone void filler) getting infected.¿ she stated: ¿they are baffled and can¿t find any infection.¿ she reported that cultures and needle aspirations have been done "at one time or another" (she doesn¿t recall when) and stated that cultures did not grow anything and nothing was taken at the ¿aspiration¿ she has no reports indicating an infection (cultures have been all negative).She reports that she has not had any revision procedures.She stated that she has had a known rare bone disease (diagnosed prior to this surgery) and takes off and on antibiotics for that.No further information was provided.

Manufacturer Narrative

This medwatch form was completed using the information provided by the initial reporter.Any missing or incomplete data is the result of the information not having been provided by the initial reporter.We are therefore unable to thoroughly complete this medwatch form.No part number or lot information was provided; therefore, no review of any device history record was possible.No patient medical records were provided.Based on the limited information provided, we are unable to determine a definitive cause for this reported event.

• Brand Name: GRAFTON DBM
• Type of Device: FILLER, BONE VOID, OSTEOINDUCTION (W/O HUMAN GROWTH FACTOR)
• Manufacturer (Section D): OSTEOTECH, INC (SUBSIDIARY OF MEDTRONIC); 201 industrial way west; eatontown NJ 07724
• Manufacturer (Section G): OSTEOTECH, INC (SUBSIDIARY OF MEDTRONIC); 201 industrial way west; eatontown NJ 07724
• Manufacturer Contact: edward wheeler ; 201 industrial way west; eatontown, NJ 07724 ; 7325422800
• MDR Report Key: 3851936
• MDR Text Key: 20454989
• Report Number: 2246640-2014-00006
• Device Sequence Number: 1
• Product Code: MBP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051195
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NOT REPORTED
• Device Catalogue Number: NOT REPORTED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/06/2014
• Initial Date FDA Received: 06/05/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention