MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	55840006545
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Pain (1994); No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Surgical history: infuse was used in the primary operation in 2019.Pre-op diagnosis: spinal stenosis procedure: navigated posterior spinal fusion levels implanted: s1 it was reported that on an unknown date, post-op, the screw was broken.Hence, the revision surgery was performed for replacement of screw and extending the fusion up to t9 for acute spinal stenosis.Patient had a primary spinal fusion from l3-s1 in 2019.One cage implanted at l3/4.Partial shaft of screw still inside the patient.Any complication to the patient was unknown.The complication is that the patient needed to have another operation in a very short time within one year of the primary surgery.She was complaining of pain down her right leg which is the side where the screw broke.
Additional Manufacturer Narrative
H3: product analysis #703861935:55840006545, lot# h5499285.Visual examination of the mas bone screw confirmed bone screw complete fracture at approximately 6 threads from the base of the bone screw head.Optical examination did not identify material defect near the area of fracture origin, which could contribute to crack propagation.Microscopic examination of the fracture surface identified gently curving convex striations through the cross-sectional area of the implant, which is indicative of cyclic fatigue until subsequent mechanical failure of the implant.D3: manufacturing site details updated.B1, b2, h1: updated for additional information.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): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao,pr TN 00792
• MDR Report Key: 10307688
• Report Number: 1030489-2020-00954
• Device Sequence Number: 803947
• Product Code: KWP
• UDI-Device Identifier: 00613994971753
• UDI-Public: 00613994971753
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 55840006545
• Device Catalogue Number: 55840006545
• Device Lot Number: H5499285
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2020
• Supplement Date Received by Manufacturer: 10/17/2020
• Initial Report FDA Received Date: 07/22/2020
• Supplement Report FDA Received Date: 11/02/2020
• 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: Required Intervention
• Patient Age: 60 YR
• Patient Weight: 68