MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC.15 INFUSE; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAG

Catalog Number # T00040

Device Problem Device Emits Odor (1425)

Patient Problem No Patient Involvement (2645)

Event Date 04/09/2015

Event Type  malfunction  

Event Description

The implant was opened in the operating room field.When the tech opened the internal package she noted that there was a foul odor coming from the package.The implant was discarded from the field and did not impact the patient.Implant will be sent back to medtronic for their own internal investigation.
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manufacturer response for cancellous chips- 30cc, medtronic cancellous chips (per site reporter).
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implant to be sent by mail today.

• Brand Name: INFUSE
• Type of Device: FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAG
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC.15; 4340 swinnea road; memphis TN 38118
• MDR Report Key: 4745352
• MDR Text Key: 5772813
• Report Number: 4745352
• Device Sequence Number: 1
• Product Code: NEK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Catalogue Number: # T00040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2015
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/09/2015
• Event Location: Hospital
• Date Report to Manufacturer: 05/04/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/09/2015
• Patient Sequence Number: 1