MAUDE Adverse Event Report: WARSAW ORTHOPEDICS ATLAS CABLE SYSTEM

Model Number 826-211

Device Problems Break (1069); Device Dislodged or Dislocated (2923); Material Protrusion/Extrusion (2979); Mechanical Jam (2983)

Patient Problem Pressure Sores (2326)

Event Date 12/25/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from healthcare professional via field representative regarding patient with unknown indication involved in spinal therapy.It was reported that on unknown event context, the atlas cable that was inserted in the first surgery in 2004 was broken and the wire part popped out and was stuck from the inside.Event was revision surgery.There were no broken fragments left in the patient's body.Product was utilized correctly according to the directions given in the ifu/labeling.Reported that it couldn't find pressure ulcers at all on the x-ray ((b)(6)) when the patient visited the hospital about a week after complaining of pressure ulcers on the skin.A lateral radiograph of the chest x-ray taken at the internal medicine department on (b)(6) showed that the fixing clasp was slightly protruding near the crosslink between th10 / 11 at the bottom of the fixation.It was thought to solve with removing the crosslink.On 2021-mar-29, received additional information that event was removal procedure.The broken cable was at implanted level.Health damage in patient was pressure ulcers on the skin.

Manufacturer Narrative

Additional information: h10, h6.H10: radiographic image review result- post-op x-ray for posterior spinal thoracic fixation.A rod and screw construct is present.There are multiple cable present as well, by report one of the cables had broken.I cannot determine which one on provided images.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: ATLAS CABLE SYSTEM
• Type of Device: CABLE
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 11663237
• MDR Text Key: 245329646
• Report Number: 1030489-2021-00483
• Device Sequence Number: 1
• Product Code: LRN
• Combination Product (y/n): N
• PMA/PMN Number: K892651
• 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: 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 826-211
• Device Catalogue Number: 826-211
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention