MAUDE Adverse Event Report: MDT PUERTO RICO OPERATIONS CO, MED REL CD HORIZON SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number G9010001550

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/24/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional via a field contact regarding a patient with a pre-operative diagnosis of lcs, undergoing a revision surgery.It was reported that tlif was performed on l5/s1 on (b)(6) 2020, but ob occurred on the left s1 screw and neurological symptoms occurred.The left s1 screw inserted by the pes method deviated to lateral.The screw was removed, the direction was changed, and the screw was inserted again.The crosslink set screw stripped.An attempt was made to remove it, but the set screw on one side stripped and could not be removed.Therefore, the rod was removed together.No force was applied on it, the set screw was stripped from the beginning.Initial reporter information cannot be provided due to the restriction by the privacy regulation.Mdt products used in initial surgery: solera55/60 elevate prolock device status reason : explanted-complete.

Manufacturer Narrative

H2: additional information received.The product will not be returned as it was discarded.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
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MDT PUERTO RICO OPERATIONS CO, MED REL; road 909, km. 0.4., barrio mar; humacao PR 00792
• MDR Report Key: 11034366
• MDR Text Key: 222310336
• Report Number: 2647346-2020-00046
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K153589
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G9010001550
• Device Catalogue Number: G9010001550
• Device Lot Number: H5629955
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1