MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Device Problems Migration or Expulsion of Device (1395); Malposition of Device (2616)

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

Event Date 11/17/2014

Event Type  malfunction  

Event Description

It was reported that a patient underwent a cervical fusion at c5-c7 with c6 corpectomy using iliac bone.After placing screws at the caudal side, the cranial screw was inserted from the right side.Then, the left screw was inserted, but it was eventually pulled out along with the driver.According to the report, it took 5 minutes to disengage the screw from the driver.The procedure was completed successfully with a new screw.The surgical time was extended 15 minutes due to the incident.The surgeon commented that the order of screw placement might have caused the incident.As caudal tightening preceded, the cranial side of the plate might have lifted up and pulled out the loosely inserted screw.The second attempt was conducted by changing the tightening order and was completed successfully.No patient complications were reported.

Manufacturer Narrative

(b)(4).Location : hospital.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.

• Type of Device: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• 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: huzefa mamoola ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 4329999
• MDR Text Key: 20779986
• Report Number: 1030489-2014-04722
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/17/2014

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: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2014
• Initial Date FDA Received: 12/15/2014
• 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
• Treatment: CERVICAL PLATE SYSTEM