MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC KYPHON CEMENT DELIVERY SYSTEM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number VPK1003

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/15/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from healthcare provider via a manufacturer representative regarding a patient who was implanted with a spinal product type for vertebral compression fracture.It was reported that curved bfd had a section break off and was therefore not  implanted in patient.There were no patient symptoms or complications as a result of this event.Procedure was completed successfully with new product.Metal piece that broke off was left inside the patient.There was additional time only needed to open and use new curved bfd.Labeling was followed throughout the procedure.

Manufacturer Narrative

B5: additional information regarding the event h6: updated eval.Code result.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.

Event Description

It was reported that they had no plans to remove the fragment as it was not causing or perceived to cause any current and future problems the duration of the delay would be the normal time to reopen new kit.Approximately 2 min.The patient is feeling normal post op outcome symptoms.

• Brand Name: KYPHON CEMENT DELIVERY SYSTEM
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 11811147
• MDR Text Key: 250245663
• Report Number: 1030489-2021-00605
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00643169414044
• UDI-Public: 00643169414044
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/16/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 09/04/2021
• Device Model Number: VPK1003
• Device Catalogue Number: VPK1003
• Device Lot Number: 0221398951
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/15/2021
• Initial Date FDA Received: 05/12/2021
• Supplement Dates Manufacturer Received: 05/14/2021
• Supplement Dates FDA Received: 07/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1