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

Catalog Number	VPT02A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/03/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The patient was over (b)(6) years old.
Additional 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
• Common Device Name: DISPENSER, CEMENT
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 10016720
• Report Number: 9612164-2020-01743
• Device Sequence Number: 2077063
• Product Code: KIH
• UDI-Device Identifier: 00763000026783
• UDI-Public: 00763000026783
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 04/03/2020
• Supplement Date Received by Manufacturer: 05/05/2020; 07/01/2020
• Initial Report FDA Received Date: 05/01/2020
• Supplement Report FDA Received Date: 06/02/2020; 07/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CEMENT
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR
• Patient Weight: 82