MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON SPINAL SYSTEM

Catalog Number	NAV2020K
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Common device name- orthopedic stereotaxic instrument.Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Image review: submitted image appears to display instrument fracture of the distal tip.
Event or Problem Description
Pre-op diagnosis: diagnostic ostomyelite l5 revision case lumbosacral.Procedure: pedicle screw revision in the lumbar/ sacral region it was reported that during surgery, the distal tip of the driver broke and was left inside the tulip of the screw in s1.The s1 right and left was prepared using the drill and the 8.5 mm tap.Then the screw was implanted using the 2 different screwdrivers in fault.Both the drives contacted the patient and broke.Fragments remained in the patient.No patient complications were reported as a result of the event.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 6975562
• Report Number: 1030489-2017-02247
• Device Sequence Number: 13776259
• Product Code: OLO
• UDI-Device Identifier: 00643169545816
• UDI-Public: 00643169545816
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K140454
• 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): 10/25/2017

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: NAV2020K
• Device Lot Number: CA16G105
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2017
• Initial Report FDA Received Date: 10/25/2017
• 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