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

Catalog Number	55811006545
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/15/2018
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.
Event or Problem Description
Pre-operative diagnosis: traumatic kyphosis.Type of procedure: psf (posterior spinal fusion) levels implanted: t11-l1.It was reported that on post-op, the lower screw of construct was disconnected.No patient complications occurred as a result of this event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Image review: post-op, x-rays for posterior spinal instrumentation of compression fracture at t12 in patient with scheuermann kyphosis show rod slippage through the interior aspect of the l3 screw head.Correction of this type of deformity should be undertaken after an assessment of the whole spine/sagittal balance.It appears that the kyphosis was corrected initially, possible simply by laying the patient prone.For this type of pathology/ longer constructs with thoracic osteotomies use often necessary to achieve proper sagittal balance.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis: two bone screws of same part lot shows a heavy amount of rubbing inside the saddle.There are gouges in the saddle where it appears the end of the rod was displacing material for the saddle.It would appear that this one screw was located the end of the construct.The witness marks inside the saddle appear to be fairly uniformed there does appear to have been some movement of the rod inside the saddle.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: 7270979
• Report Number: 1030489-2018-00216
• Device Sequence Number: 19395343
• Product Code: KWP
• UDI-Device Identifier: 00643169058187
• UDI-Public: 00643169058187
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K122433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 06/15/2018

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: 55811006545
• Device Lot Number: CT14F085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2018
• Initial Date Received by Manufacturer: 01/15/2018
• Supplement Date Received by Manufacturer: 02/12/2018; 05/03/2018; 04/16/2018; 05/18/2018
• Initial Report FDA Received Date: 02/14/2018
• Supplement Report FDA Received Date: 03/09/2018; 05/02/2018; 05/16/2018; 06/15/2018
• 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: Required Intervention
• Patient Age: 17 YR
• Patient Weight: 110