inforMED
MalfunctionOCJ

NA

Received Sep 9, 2025 · Event occurred Aug 19, 2025

Report 23004049 · MDR key 23004049

Device

Generic name

Spinal Channeling Instrument, Vertebroplasty

Model number

0306621000

Catalog number

0306-621-000

Lot number

10435915

Product problems

  • Break
  • Difficult to Remove

Patient

82 YR · Female

  • Foreign Body In Patient
  • Foreign Body In Patient

Narrative

Description of Event or Problem

WE WERE PERFORMING A MULTIPLE LEVEL KYPHOPLASTY ON THE PATIENT. WE WERE WORKING ON THE L1 VERTEBRAE AND AFTER ACCESS WAS GAINED USING THE 11G ACCESS NEEDLE, THE 11G CURETTE WAS INTRODUCED. THE 11G CURETTE IS USED TO DISPLACE SCLEROTIC/CANCELLOUS BONE DURING PERCUTANEOUS BALLOON-ASSISTED VERTEBRAL AUGMENTATION PROCEDURES. THE CURETTE WAS INSERTED, AND THE PHYSICIAN WAS TAPPING THE DEVICE TO DISPLACE THE SCLEROTIC BONE WHEN THE CURETTE BECAME LODGED IN THE BONE. THE DEVICE WAS THEN TWISTED TO TRY AND DISPLACE THE BONE WHEN THE TIP OF THE DEVICE SHEARED OFF AND THE DISTAL PORTION OF THE CURETTE BROKE OFF, LEAVING A PIECE OF THE DEVICE IN THE VERTEBRAL BODY. THE TIP OFF THE CURETTE WAS WEDGED TO FAR WITHIN THE BONE AND NO ATTEMPT TO RETRIEVE IT WAS MADE. THE DECISION WAS MADE TO LEAVE THE FOREIGN BODY IN PLACE AND FILL THE VERTEBRAL BODY WITH CEMENT. THE STRYKER REP [REPRESENTATIVE] WAS PRESENT AND DISCOVERED THE PARTS OF THE METAL ARE MADE OF NITINOL AND MANY OF THE IMPLANTS USED TODAY ARE MADE OF THIS MATERIAL.