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

Catalog Number	7575300
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/02/2018
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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient was pre-operatively diagnosed with spinal stenosis and underwent fusion surgery at l5-s1.During the surgery, the rod dislodged from the rod inserter and was retrieved and reattached on the inserter.The product came in contact with the patient.No patient complications occurred in the event.
Additional Manufacturer Narrative
Product analysis: visual examination of the instrument did not reveal any material or functional damage in terms of fracture, cracking, breakage, deformation or missing components.Rod inserter attachment arms and levers open and close and function normally.Rod inserter rod attachment lever opens normally.Functional evaluation of the instrument tip confirmed the inserter properly retained and released a sample rod with no issues.Unable to confirm customer concern; after visual and functional evaluation, the instrument appears to function as intended.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: 8026741
• Report Number: 1030489-2018-01434
• Device Sequence Number: 16489028
• Product Code: KWP
• UDI-Device Identifier: 00885074445380
• UDI-Public: 00885074445380
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K051674
• 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): 02/08/2019

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: 7575300
• Device Lot Number: M06B0062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2018
• Initial Date Received by Manufacturer: 10/02/2018
• Supplement Date Received by Manufacturer: 01/11/2019
• Initial Report FDA Received Date: 10/31/2018
• Supplement Report FDA Received Date: 02/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1