MAUDE Adverse Event Report: MEDFIX INTERNATIONAL, LLC LENKE PEDICLE PROBE

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/25/2022

Event Type  Injury  

Event Description

During spinal fusion surgery, lenke navigation probes were used.The patient had a preexisting condition (diffuse idiopathic skeletal hyperostosis) which made the bone of the vertebra dense.In the attempt to place pedicle screws, the tip of two lenke probes fractured.The fragmented instrumentation was unable to be safely removed, but opined to be in a place of safety, extremely unlikely to migrate into a dangerous position.Fda safety report id# (b)(4).

• Brand Name: LENKE PEDICLE PROBE
• Type of Device: PROBE
• Manufacturer (Section D): MEDFIX INTERNATIONAL, LLC
• MDR Report Key: 14622353
• MDR Text Key: 293550347
• Report Number: MW5110136
• Device Sequence Number: 2
• Product Code: HXB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/02/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 103 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White