MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Catalog Number 7570905

Device Problem Bent (1059)

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

Event Date 02/02/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the patient was pre-operatively diagnosed with degenerative disc disease and underwent minimally invasive lumbar decompression and fusion at l3-s1.During surgery, the sleeves each ¿popped¿ off when surgeon was attempting to reduce rod into screw head.The sleeves appear bent.The product came in contact with the patient.No patient complications were reported as the result of the event.

Manufacturer Narrative

Device evaluation: visual, functional and microscopic examination found that one side of the reducer¿s tip is bent outward.This type of damage is consistent with overload through bending while attached to the screw.There are witness marks on the location tab indicating the screw had slipped off.The observation are consistent with bend stress overload.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 7291589
• MDR Text Key: 100920761
• Report Number: 1030489-2018-00265
• Device Sequence Number: 1
• Product Code: KWP
• UDI-Device Identifier: 00613994302755
• UDI-Public: 00613994302755
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K052747
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7570905
• Device Lot Number: FA14F008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1