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

Model Number	VPT02A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Similar device 510k: k070527; k063248.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from hcp via manufacturing representative regarding patient with indication of osteoporosis for spinal therapy.The event occurred intra-op.Patient demographics: (b)(6).It was reported that the curve was inside vertebral body when the snap was heard by doctor.The bone was super soft without sclerotic pockets.The doctor wasn't twisting it around or doing anything that would cause stress on the metal.He was advancing it through very soft bone.After the snap was heard, he pulled it out and the curve was broken at the tip holding together by a thread and came apart as soon as it was out of the cannula.Hcp was demanding a full report to be provided to him.Product will be returned back.No patient symptoms were reported.No further complications reported.
Event or Problem Description
Information was received from hcp via manufacturing representative regarding patient with indication of osteoporosis for spinal therapy.The event occurred intra-op.It was reported that the curve was inside vertebral body when the snap was heard by doctor.The bone was super soft without sclerotic pockets.The doctor wasn't twisting it around or doing anything that would cause stress on the metal.He was advancing it through very soft bone.After the snap was heard, he pulled it out and the curve was broken at the tip holding together by a thread and came apart as soon as it was out of the cannula.Hcp was demanding a full report to be provided to him.Product will be returned back.No patient symptoms were reported.No further complications reported.Procedure planned was kyphoplasty.
Additional Manufacturer Narrative
H3: product analysis #703848431:part # vpt02a lot # 219060536 visual and optical inspection revealed a portion of the tip of the curved needle has broken off.The fracture edges are slightly angled and rigid.This type of damage is consistent with bend stress overload.If information is provided in the future, a supplemental report will be issued.

• Brand Name: KYPHON KURVE BONE FILLER DEVICE 13GA
• Common Device Name: DISPENSER, CEMENT
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 10269352
• Report Number: 9612164-2020-02567
• Device Sequence Number: 824526
• 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: SEE H10
• 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
• Report Date (Section B): 11/06/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/10/2020
• Device Model Number: VPT02A
• Device Catalogue Number: VPT02A
• Device Lot Number: 219060536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2020
• Supplement Date Received by Manufacturer: 11/06/2020
• Initial Report FDA Received Date: 07/14/2020
• Supplement Report FDA Received Date: 11/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 54