MAUDE Adverse Event Report: MEDTRONIC MEDTRONIC GRAFTON ALLOGRAFT PUTTY; FILLER BONE ALLOGRAFT PUTTY

Model Number T43I05

Device Problem Insufficient Information (3190)

Patient Problems Cellulitis (1768); Purulent Discharge (1812); Erythema (1840); Post Operative Wound Infection (2446)

Event Date 04/25/2014

Event Type  No Answer Provided  

Event Description

Pt developed a surgical site infection following left knee arthroscopy with removal of loose ocd lesion; chondroplasty patella and trochlea; open anterior medialization tibial tubercle with distalization 8mm (3 x 4.5 mm low profile cortical screws); bone grafting at tibial tubercle defect site; open excision media patellar exostosis; open repair patellar sided mpfl/medical retinaculum.Ssi evident on (b)(6) 2014.Symptoms include pus like drainage, erythema, some cellulitis.Preliminary culture report clostridium perfringens from tissue and wound swab obtained during irrigation and debridement done on obtained during irrigation and debridement done on (b)(6) 2014.Wbc 19.2.Other tissue/devices used in surgery.Mft item# 400053 serial no: (b)(4) cort/canc granules 5 cc.Medtronic sofamor danek ref t43i05 sn (b)(4) putty 5 cc.Dyonics rf hook 30 degree probe with integrated cable ref 72202145.Cortical screw ref c2840 4.5mm x 40mm.Cortical screw ref c2844 4.5mm x 44mm.

• Brand Name: MEDTRONIC GRAFTON ALLOGRAFT PUTTY
• Type of Device: FILLER BONE ALLOGRAFT PUTTY
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 3802973
• MDR Text Key: 4369232
• Report Number: MW5035950
• Device Sequence Number: 1
• Product Code: MBP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/29/2014
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 12/19/2016
• Device Model Number: T43I05
• Device Catalogue Number: T43I05
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: IMPLANTED DATE:; CORT/CANC GRANULES: MTF REF #400053,; MUSCULOSKELETAL TRANSPLANT FOUNDATION; SERIAL #(B)(4), EXPIRATION DATE: 07/10/16,
• Patient Outcome(s): Hospitalization
• Patient Age: 19 YR
• Patient Weight: 98