MAUDE Adverse Event Report: ALPHATEC SPINE, INC. CURVED LUMBAR LENKE PROBE

Model Number Z30M1004

Patient Problem Insufficient Information (4580)

Event Date 08/02/2023

Event Type  malfunction  

Event Description

Mid-case, fluoroscopy was performed on patient.Image showed fragment in area near spine.Doctor viewed image and patient and asked for a lateral view, image again showed small object not attached to any previous hardware.Doctor then found that the tip of an instrument recently used was missing.The surgical team compared the instrument to another and confirmed the tip was missing.Doctor then worked to retrieve the tip and was successful in recovering it.Gross examination performed as well as fluoroscopy to ensure nothing was left behind.

• Brand Name: CURVED LUMBAR LENKE PROBE
• Type of Device: PROBE
• Manufacturer (Section D): ALPHATEC SPINE, INC.; 1950 camino vida roble; carlsbad CA 92008
• MDR Report Key: 17555481
• MDR Text Key: 321233510
• Report Number: 17555481
• Device Sequence Number: 1
• Product Code: HXB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 08/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: Z30M1004
• Device Catalogue Number: Z30M1004
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/08/2023
• Event Location: Hospital
• Date Report to Manufacturer: 08/16/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24090 DA
• Patient Sex: Female