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

Model Number VPT02A

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/13/2020

Event Type  malfunction  

Manufacturer Narrative

Similar device 510k: k070527; k063248.If information is provided in the future, a supplemental report will be issued.

Event 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 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.

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
• Type of Device: DISPENSER, CEMENT
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 10269352
• MDR Text Key: 198699397
• Report Number: 9612164-2020-02567
• Device Sequence Number: 1
• Product Code: KIH
• UDI-Device Identifier: 00763000026783
• UDI-Public: 00763000026783
• Combination Product (y/n): N
• PMA/PMN Number: SEE H10
• 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: 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 11/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 54