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

Catalog Number	7576301
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/29/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that the patient was pre-operatively diagnosed with spondylolisthesis(l4-5), stenosis(l5-s1) and underwent transforaminal lumbar interbody fusion at l4-s1.During surgery, the multi-level reduction extenders were being used to place screws at l4, l5, and s1.While reducing, the l5 extender disengaged from the saddle of the screw.At this point, a cannulated screwdriver was connected and the extender and the screw were removed.Reduction continued until the l4 extender disengaged.Again the extender and the screw were removed and replaced in the l4 body.The surgeon then decided not to reduce the l4 screw.The rod and set screws were placed in an open fashion.The products came in contact with the patient.No patient complications were reported as a result of the event.
Additional Manufacturer Narrative
Product analysis: a visual review confirmed that there were witness marks on two of the inner sleeves were it appeared that the screw dislodged.A functional review of all the sleeves with some sample bone screws was conducted and the events of the complaint could not be recreated.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 7302181
• Report Number: 1030489-2018-00291
• Device Sequence Number: 16475882
• Product Code: KWP
• UDI-Device Identifier: 00613994235589
• UDI-Public: 00613994235589
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K063417
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 7576301
• Device Lot Number: SV15D002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2018
• Initial Date Received by Manufacturer: 02/06/2018
• Supplement Date Received by Manufacturer: 04/20/2018
• Initial Report FDA Received Date: 02/28/2018
• Supplement Report FDA Received Date: 05/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR