MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SPINAL SYSTEM

Catalog Number	55840007550
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/20/2020
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 on (b)(6) 2020, the patient underwent a revision surgery at l4-s1.The patient had undergone the initial surgery on (b)(6) 2019.During the revision surgery, after the surgeon removed 5 out of the 6 (7.5mm x 50mm) screws that were placed a year ago; and when removing the last screw, the upper part of the screw came out with the driver leaving the lower part (roughly 25mm-30mm) of the screw in the vertebral body.The lower part was then removed using a broken screw removal tool.Images of broken screw are not available because screw did not appear to be broken in the pre-operative images.No fragment of the broken screw remained inside the patient and no patient complications were reported as a result of this event.
Additional Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The reason for the revision had no relation with the broken screw.The specific reason for performing the revision surgery is not known.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• MDR Report Key: 10173824
• Report Number: 1030489-2020-00668
• Device Sequence Number: 17046819
• Product Code: NKB
• UDI-Device Identifier: 00643169004351
• UDI-Public: 00643169004351
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K113174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2020

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: 55840007550
• Device Lot Number: H5488731
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/20/2020
• Supplement Date Received by Manufacturer: 06/19/2020
• Initial Report FDA Received Date: 06/19/2020
• Supplement Report FDA Received Date: 07/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 128