MAUDE Adverse Event Report: WARSAW ORTHOPEDICS CD HORIZON SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	8115539
Medical Device Problem Codes	Device Slipped (1584); Mechanics Altered (2984)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: visual and microscopic review confirms that the tip on the break off screws was fractured.A microscopic review of the fracture face reveals that the fracture is consistent with torsional overload with a bending moment introduced as the screw head pushed against the rod.If the screw is driven deeper using the inner hex after the break-off portion of the screw head has come off, there is a chance to overload the tip of the screw.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from healthcare professional via field representative regarding patient with symptoms of spondylolisthesis involved in posterior lumbar 4 laminectomy, lumbar 45 discectomy, spinal canal decompression, nerve root lysis, lumbar 4 spondylolisthesis open reduction, lumbar 45 intervertebral and posterolateral bone grafting, pedicle screw internal fixation used in spinal therapy.It was reported during intra-op, instrument slipped and could not be fixed.Product came in contact with patient.There is no patient complications reported as a result of the event.Instrument did not break and no fragment left in the patient.There is no additional surgery performed.Patient is alive and no injury.
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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 10706125
• Report Number: 1030489-2020-01447
• Device Sequence Number: 3645323
• Product Code: KWP
• UDI-Device Identifier: 00721902729669
• UDI-Public: 00721902729669
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K030840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2021

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 Model Number: 8115539
• Device Catalogue Number: 8115539
• Device Lot Number: 0654181W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2020
• Supplement Date Received by Manufacturer: 02/25/2021
• Initial Report FDA Received Date: 10/20/2020
• Supplement Report FDA Received Date: 03/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR