MEDTRONIC GRAFTON ALLOGRAFT PUTTY T43I05

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-05-05 for MEDTRONIC GRAFTON ALLOGRAFT PUTTY T43I05 manufactured by Medtronic.

Event Text Entries

[4369232] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5035950
• MDR Report Key: 3802973
• Date Received: 2014-05-05
• Date of Report: 2014-04-29
• Date of Event: 2014-04-25
• Date Added to Maude: 2014-05-12
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: MEDTRONIC GRAFTON ALLOGRAFT PUTTY
• Generic Name: FILLER BONE ALLOGRAFT PUTTY
• Product Code: MBP
• Date Received: 2014-05-05
• Model Number: T43I05
• Catalog Number: T43I05
• Device Expiration Date: 2016-12-19
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MEDTRONIC

Device Sequence Number: 2

• Brand Name: DYONICS RF HOOK 30 DEGREE PROBE WITH INTEGRATED CABLE
• Generic Name: ELECTROSURGICAL CUTTING AND COAGULATION
• Product Code: GEI
• Date Received: 2014-05-05
• Catalog Number: 72202145
• Device Sequence No: 2
• Device Event Key: 0

Device Sequence Number: 3

• Brand Name: CORTICAL SCREW 4.5MM X 40MM
• Generic Name: SCREW
• Product Code: HWC
• Date Received: 2014-05-05
• Catalog Number: C2840
• Device Sequence No: 3
• Device Event Key: 0

Device Sequence Number: 4

• Brand Name: CORTICAL SCREW 4.5MM X 44MM
• Generic Name: SCREW
• Product Code: HWC
• Date Received: 2014-05-05
• Catalog Number: C2844
• Device Sequence No: 4
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	2014-05-05