MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number	5484902
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	07/01/2020
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 presented with l2 burst fracture, and underwent spinal fusion at two levels above and two levels below l2.Intra-op, while turning the sequential reducer on the left side of l3 to push the rod down, the extender disconnected from the reported sequential reducer and the rod could not be placed.The same had occurred previously with another sequential reducer but same extender.Hence, it was then thought that the sequential reducer was not responsible for the reported event.The pedicle screw was loosened slightly and the bending of the rod was checked, but no change about the situation occurred.Finally, the extender at left side of l3 was removed, the rod was placed with an offset counter torque and the set screw was inserted.There was a delay of less than 60 minutes in the overall procedure time as a result of this event, but no patient complications were reported.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 10287281
• Report Number: 1030489-2020-00925
• Device Sequence Number: 1073710
• Product Code: NKB
• UDI-Device Identifier: 00643169177024
• UDI-Public: 00643169177024
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K122862
• 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
• Report Date (Section B): 07/17/2020

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: 5484902
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2020
• Initial Report FDA Received Date: 07/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR