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	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Common device name: orthopedic stereotaxic instrument.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
It was reported that the patient underwent posterior lumbar fusion at l3-pelvis.Intra-operatively, during the placement of screw , the tip of the drive broke-off inside screw.The broken piece was removed and thrown out.No fragments of the product remained inside patient.The product came in contact with patient.No patient complications were reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 6568405
• Report Number: 1030489-2017-01230
• Device Sequence Number: 18860885
• 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,Followup
• Report Date (Section B): 04/20/2017

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: NAV2020K
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/20/2017
• Supplement Date Received by Manufacturer: 04/20/2017
• Initial Report FDA Received Date: 05/16/2017
• Supplement Report FDA Received Date: 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 95