MAUDE Adverse Event Report: BK MEDITECH CO.,LTD. MEGA PLUS MIS SPINE SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/08/2022

Event Type  malfunction  

Event Description

Bk meditech sounder instrument broke in patient during placement of patient screws.Surgeon attempted to retrieve the broken piece of the instrument in the bone and determined it to be safer to leave the piece in place.Bk meditech vendor representative aware.The bk meditech sounder instrument removed from use.

• Brand Name: MEGA PLUS MIS SPINE SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): BK MEDITECH CO.,LTD.; 415 valley view trail; houlton WI 54082
• MDR Report Key: 16282896
• MDR Text Key: 308630933
• Report Number: 16282896
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/18/2023
• Date Report to Manufacturer: 02/02/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 6935 DA