MAUDE Adverse Event Report: MEDTRONIC MEXICO KYPHON KURVE CURVED BONE FILLER DEVICE; DISPENSER, CEMENT

Catalog Number VPT02A

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/03/2020

Event Type  Injury  

Manufacturer Narrative

Other: device fragment in patient.Product was not 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

It was reported that the patient had an osteoporotic compression fracture at t11 and l1; and underwent unipedicular kyphoplasty at these two levels.Intra-op, the distal tip of the curved needle sheared off while it was being removed from the patient.The broken distal tip remained in the l1 vertebral body and was cemented in place.After 15 minutes into the cementing process, the cement became too hard to push out of the cement cartridge (the room temperature was 77° f).The cement cartridge was removed from the needle and it was attempted to pull the needle out through the 10 guage cannula.The physician could not remove the needle with his hands.So, he used a pair of ring forceps which he clamped onto the shaft of the needle.While attempting to pull out the needle, the physician twisted and snapped the shaft of the needle in half.He then removed the cannula leaving the needle in the vertebral body and again used forceps to pull out the needle.After several attempts, the distal tip of the needle sheared off.Some part was removed while remainder of the distal needle remained in the patient at l1 vertebral body.No injury to the patient has been reported yet.

Manufacturer Narrative

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

Event Description

The patient was over (b)(6) years old.

Manufacturer Narrative

H6: product analysis: visual and optical inspection revealed, the shaft of the instrument has bent and broke off.The shaft is filled with dried cement.It appears to the shaft broke, due to bend stress overload, during the removal process.Additional information: d10, g1, g2, h3, h6.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: KYPHON KURVE CURVED BONE FILLER DEVICE
• Type of Device: DISPENSER, CEMENT
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 10016720
• MDR Text Key: 196089302
• Report Number: 9612164-2020-01743
• Device Sequence Number: 1
• Product Code: KIH
• UDI-Device Identifier: 00763000026783
• UDI-Public: 00763000026783
• 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,Followup
• Report Date: 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/04/2020
• Device Catalogue Number: VPT02A
• Device Lot Number: 218798041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2020
• Date Manufacturer Received: 07/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CEMENT
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Weight: 82