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

Catalog Number	9010000849
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/29/2018
Type of Reportable Event	Serious Injury
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 leg pain due to degenerative scoliosis and underwent posterior lumbar interbody fusion.During surgery, the rod inserter could not grasp strongly and was broken but it was able to connect with the rod.Because the product was weak to grip the rod, adjustment was performed during the operation.Adjustment was made with raising the latch by two steps, but it can not interlock even if the adjustment tension knob was turned.The rod was inserted finally in a state of the product loosened.Fragments of the broken part remained in the patient.Patient complications were reported to be unknown.There was a delay of less than 60 minutes.
Additional Manufacturer Narrative
Visual and functional evaluation confirmed that the inner shaft does not move when the locking lever is moved.The "c" clip (9010000849-18) that connects the adjusting mechanism to the shaft appears to have come out.It is possible to overload the clip if making tension adjustments while the rod is in place.It appears that the clip may have been overloaded.Due to imdrf harmonization, some previously submitted device, method, result, and conclusion codes related to this event may have been updated.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: 7645151
• Report Number: 1030489-2018-00924
• Device Sequence Number: 122044
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 9010000849
• Device Lot Number: RS16L018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2018
• Initial Date Received by Manufacturer: 05/29/2018
• Supplement Date Received by Manufacturer: 10/15/2018
• Initial Report FDA Received Date: 06/28/2018
• Supplement Report FDA Received Date: 11/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other