MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK

Catalog Number UNKNOWN

Device Problem Metal Shedding Debris (1804)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/26/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Multiple products used, but it is unknown which product caused the event.Suspected products are: 7068396 (quantity -1) lot number - h5180564 unknown screw (quantity-1), lot number - unknown.Device evaluation anticipated, but not yet begun.

Event Description

It was reported that patient underwent plif surgery at l5-s1 levels for l5 spondylolisthesis.During surgery, metal fragments on dura mater were observed after breaking off.The surgeon required the analyzing of the fragments and examining if these were setscrew's burrs or not.The surgical time was extended less than 15mins.No patient complications were reported as a result of the event.Patient info is unknown.It was reported that metal fragments were found after compression and final tightening were done.The fragments were about 1ױmm in size and were found on microscope.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: UNK
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• 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: 5305356
• MDR Text Key: 34440127
• Report Number: 1030489-2015-03467
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/26/2015
• 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