MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV KYPHON XPANDER II INFLATABLE BONE TAMP; ARTHROSCOPE

Model Number KPX203RB-C

Device Problems Leak/Splash (1354); Nonstandard Device (1420); Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/24/2020

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.Product is not marketed in us.510(k) for similar device marketed in us with catalogue#kpx203rb is k101864.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider via a manufacturer representative regarding a patient with pre-operative diagnosis of vertebral compression fracture.It was reported that intra-op, luer-lock connection of the bone fillers are not frictional.There was no strong connection to the adapter.Hence there was cement leakage between the bone fillers and the adapter.Surgeons can not get enough cement to fill the cavity of the vertebra.The whole of the luer-lock connection of the bone fillers are too big in a diameter.Surgeon and nurse pressed the fillers to the adapter and get some cement, use of the adapter was discontinued and syringe was used to get more cement.There were no patient complications associated with the event.Surgery was completed successfully.There was a delay of 3 minutes in overall procedure time.No leakage in the patient.Bone fillers always in contact with the patient.We pressed the bone fillers with 4 hands to the adapter.

• Brand Name: KYPHON XPANDER II INFLATABLE BONE TAMP
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer Contact: tricha miles ; 1800 pyramid place; memphis, TN 38132 ; 7635140379
• MDR Report Key: 11001835
• MDR Text Key: 221219965
• Report Number: 9617601-2020-00034
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/14/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 05/29/2022
• Device Model Number: KPX203RB-C
• Device Catalogue Number: KPX203RB-C
• Device Lot Number: 220867570
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/24/2020
• Initial Date FDA Received: 12/14/2020
• Date Device Manufactured: 10/06/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1