MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS CD HORIZON SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Catalog Number 54740016545

Device Problem Malposition of Device (2616)

Patient Problem Pain (1994)

Event Date 01/22/2015

Event Type  Injury  

Event Description

It was reported that the patient underwent a spinal surgical procedure using fluoroscopic imaging for screw placement.Post-op it was reported that the patient complained of pain.A ct scan revealed that the screw was ¿ob too medially¿, a revision was performed to remove and replace the screw.No additional patient complications were reported.

Manufacturer Narrative

(b)(4): this part is not approved for use in the united states; however a like device catalog # 54840016545, 510k # k091974 was cleared in the united states.Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS; road 909, km. 0.4 bo. mariana; humacao PR 00792
• 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: 4534268
• MDR Text Key: 5538116
• Report Number: 1030489-2015-00341
• 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: Other
• Type of Report: Initial
• Report Date: 01/26/2015

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 54740016545
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/26/2015
• Initial Date FDA Received: 02/23/2015
• 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