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

Catalog Number 751090001

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

Patient Problem Bacterial Infection (1735)

Event Date 10/31/2012

Event Type  Injury  

Manufacturer Narrative

(b)(6).Neither device nor applicable imaging studies returned to manufacturer for evaluation.

Event Description

Primary diagnosis: contamination of hematic flow with corynebacterium urealyticumum.Following the resection of a hematoma (first adverse event) the analysis of the hematic flow revealed a contamination with corynebacterium urealyticumum on (b)(6) 2012.Diagnostics: - cyto-bacteriologic analysis abnormal: presence of corynebacterium urealyticumum in haematic flow.((b)(6) 2012) sponsor and investigator assessment - rh-bmp2/acs relatedness: not related - study procedure relatedness: related - device/other component relatedness, specify: not related.Outcome: - resolved without sequelae: 21-mar-2013.

• 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: 5099794
• MDR Text Key: 26598076
• Report Number: 1030489-2015-02491
• 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: 08/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 751090001
• Device Lot Number: 4501764237
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2015
• 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: 00065 YR
• Patient Weight: 103