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

Catalog Number	9010000849
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/10/2019
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 vertebral body fracture at l1 and underwent vertebroplasty and fixation at th11-l3.During the surgery, problem occurred when gripping the rod.It seemed that the tip of the rod inserter narrow was broken and that the rod and the inserter were not tightly fitted.There was a delay of less than 60 minutes in overall procedure time.The product came in contact with the patient.No fragments of the broken inserter remained inside the patient.No patient complications were reported as the result of the event.
Additional Manufacturer Narrative
Product analysis results: visual and optical examination identified that the inner shaft does not move when the locking lever is moved.The c clip that connects the adjusting mechanism to the shaft appears to have come out.It is possible to overload the clip if making tensioning adjustment while the rod is in place.It appears that the clip may have been overloaded.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: 8319492
• Report Number: 1030489-2019-00121
• Device Sequence Number: 2285341
• Product Code: KWP
• UDI-Device Identifier: 00643169359987
• UDI-Public: 00643169359987
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K132639
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2019

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: 9010000849
• Device Lot Number: RS15F010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2019
• Initial Date Received by Manufacturer: 01/10/2019
• Supplement Date Received by Manufacturer: 01/10/2019
• Initial Report FDA Received Date: 02/08/2019
• Supplement Report FDA Received Date: 05/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1