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 Insufficient Information (3190)

Patient Problems Hematoma (1884); Pain (1994); Scarring (2061)

Event Date 09/26/2012

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2012, the patient fell of the bed on the scar.On (b)(6), the scar was very painful (eva=3).So after a verification by irm, the patient was re-operated 5 days later to remove the hematoma.The patient was diagnosed with suspicious presence of hematoma in an mri on (b)(6) 2012.Patient was hospitalized for a longer duration.Event was resolved without sequelae on (b)(6) 2012.

Manufacturer Narrative

(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.Products from multiple manufacturers were implanted during the procedure.Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.

• 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: 4927135
• MDR Text Key: 6430101
• Report Number: 1030489-2015-01526
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/23/2015

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: 08/31/2014
• Device Catalogue Number: 751090001
• Device Lot Number: 4501712312
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/23/2015
• Initial Date FDA Received: 07/21/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/14/2012
• 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: 00078 YR
• Patient Weight: 75