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

Model Number T43105

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Purulent Discharge (1812); Erythema (1840); Headache (1880)

Event Date 04/25/2014

Event Type  Injury  

Event Description

It was reported that a (b)(6) male patient received allograft bone void filler during a ¿left knee arthroscopy with removal of loose ocd (osteochondritis dissecans) lesion; chondroplasty of the patella and trochlea; open anteromedialization tibial tubercle with distalization 8mm (3 x 4.5 mm low profile cortical screws); bone grafting at tibial tubercle defect site; open excision medial patellar exostosis; open repair patellar sided mpfl (medial patellofemoral ligament) / medial retinaculum." approximately one month later, the patient returned to the er with pus-like drainage from the incision complaining of feeling feverish, erythema and headache.The patient was admitted to the hospital that same day and underwent an open debridement drainage and irrigation.Patient was started on antibiotics.Two days later, the patient was returned to surgery for incision and drainage.Patient was started on additional antibiotics.Another two days later, the patient was again returned to surgery for incision and drainage.The graft remains in the patient.The patient was discharged from the hospital approximately 5 weeks after his readmission.

Manufacturer Narrative

(b)(4).All donor records and manufacturing records relative to the subject graft were reviewed and indicated that the graft was manufactured according to procedure and met all required specifications; all final product sterility and environmental monitoring test results complied.There were no non-conformances associated with the manufacture of the product.The donor records were reviewed by the medical director; the donor was confirmed to have been appropriately screened and tested in accordance with the manufacturer¿s donor suitability criteria, and was deemed eligible for transplantation.All infectious disease tests were non-reactive (compliant).The donor tissue underwent low dose pre-processing irradiation with gamma radiation within the required dosage rate.The tissue recovery organization which provided the donor tissue to the manufacturer was notified of this incident, and they have received no additional reports of infection of any type involving any other tissues procured from this donor.The manufacturer has not received any other reports of infection involving any other grafts manufactured from this lot or from this donor tissue.Based on these findings, the medical director has concluded that there is no medical evidence to indicate that the subject graft caused or contributed to the patient's infection, which occurred one month post-op.No further action is required at this time and this event is considered closed.

• 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: 3839463
• MDR Text Key: 4683820
• Report Number: 2246640-2014-00005
• 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: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/29/2014

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 Expiration Date: 12/19/2016
• Device Model Number: T43105
• Device Catalogue Number: T43105
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/29/2014
• Initial Date FDA Received: 05/29/2014
• Date Device Manufactured: 12/31/2013
• 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): Hospitalization; Required Intervention
• Patient Age: 00019 YR
• Patient Weight: 98