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

Catalog Number VPT02A

Device Problem Break (1069)

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

Event Date 05/22/2019

Event Type  malfunction  

Manufacturer Narrative

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

It was reported that the patient underwent kyphoplasty and vertebral compression fracture surgery at l1 due to some unknown reason.Intra-op, bone filler syringe (bfs) was broken approximately 1 inch from the end of bone filler device (bfd).No patient complications were reported as a result of this event.

Manufacturer Narrative

Additional information received: product analysis results: visual optical visual and optical inspection confirmed the curved bfd tip has been broken off but no damage to the handle or the inner plastic tube.Optical inspection of the fracture surface confirmed a fairly brittle surface with an angulated edge.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: 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: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 8715143
• MDR Text Key: 148956976
• Report Number: 9612164-2019-02439
• Device Sequence Number: 1
• Product Code: KIH
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/24/2019
• Device Catalogue Number: VPT02A
• Device Lot Number: WI527027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1