MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INDUCTOS; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

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

Patient Problems Fever (1858); Staphylococcus Aureus (2058); Scarring (2061)

Event Date 01/23/2013

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4).Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.

Event Description

Primary diagnosis:spondylolisthesis it was reported that on (b)(6) 2012 patient underwent surgery involving rhbmp-2/acs.Pots-op on (b)(6) 2013, patient was hospitalized because of a confusional syndrom, fever, diarrhea and an abscess on the top of the study surgery scar.Patient also showed an infection with (b)(6).Gastric fibroscopy and abdominal ultrasound were performed (b)(6) 2015 and patient showed no more complication.The blood analysis was normal and blood culture was free of germs.

• Brand Name: INDUCTOS
• Type of Device: FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5090348
• MDR Text Key: 26229991
• Report Number: 1030489-2015-02415
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P000058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Health Professional
• Report Date: 08/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2015
• Was Device Evaluated by Manufacturer?: No
• 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): Other
• Patient Age: 00075 YR
• Patient Weight: 91