MAUDE Adverse Event Report: MEDTRONIC MEXICO 13 GA CURVED BONE FILLER DEVICE; DISPENSER, CEMENT

Model Number VPT02A

Device Problem Material Separation (1562)

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

Event Date 09/01/2021

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #: class i exempt.Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having spinal therapy.It was reported that while injecting xpede cement with cds gun thru kurve bone filler device the purple hub (where cement cartridge is attached) popped off/separated from metal portion of kurve bone filler device.There was cement in the kurve bone filler device as well.Dr (b)(6) then used forceps to remove cannula and kurve bone filler device from patient.There were no fragments left in the patient. there were no patient symptoms reported.There were no further complications reported regarding the event.

Manufacturer Narrative

User report# (b)(4) has been received for this event h3.Device evaluation summary: product analysis #272570330: vpt02a 222477700 visual the purple hub has separated from the shaft of the bone filler device.There is dried cement in the hub and the shaft.The knurling and the flare are both on the end of the shaft.Because of the damage to the material surfaces, a root cause could not be determined.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

Additional information was received regarding the event.It was reported that the patient was having vertebral augmentation of l2 for the diagnosis of vertebral compression fracture.

• Brand Name: 13 GA CURVED BONE FILLER DEVICE
• Type of Device: DISPENSER, CEMENT
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 12504052
• MDR Text Key: 273589236
• Report Number: 9612164-2021-03617
• Device Sequence Number: 1
• Product Code: KIH
• UDI-Device Identifier: 00763000311834
• UDI-Public: 00763000311834
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/25/2023
• Device Model Number: VPT02A
• Device Catalogue Number: VPT02A
• Device Lot Number: 222477700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Sex: Male
• Patient Weight: 104 KG
• Patient Race: White