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

Catalog Number	NAV2024
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/14/2017
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.
Event or Problem Description
It was reported that on (b)(6) 2017, patient was pre-operative diagnosed with spinal fracture and underwent s2 sacral iliac trajectory with the torque multiplier.Intra-op, the tip of the screw driver broke.Tip of screw driver could not be recovered from the head of screw.Hence, the tip of the driver was left inside the patient and this did not impact the final tightening of the construct.No patient complications were reported.
Additional Manufacturer Narrative
Product analysis: visually confirmed approximately ~3mm of instrument tip has been broken off, consistent with interface during usage.Inspection of the shaft diameter and material hardness confirmed conformance to print specification.Optical examination of the fracture surface identified a fairly flat fracture surface and circular material displacement.The above findings are consistent with torsional overload.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 6621248
• Report Number: 1030489-2017-01463
• Device Sequence Number: 781844
• Product Code: OLO
• UDI-Device Identifier: 00643169693821
• UDI-Public: 00643169693821
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K140454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2017

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: NAV2024
• Device Lot Number: CA14J036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2017
• Initial Date Received by Manufacturer: 05/14/2017
• Supplement Date Received by Manufacturer: 06/30/2017
• Initial Report FDA Received Date: 06/08/2017
• Supplement Report FDA Received Date: 07/25/2017
• 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