MAUDE Adverse Event Report: LESSPINE INNOVATIONS PEDFUSE; PEDICLE SCREW SYSTEM

Model Number 01-80325

Device Problem Break (1069)

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

Event Type  Injury  

Manufacturer Narrative

Medical intervention was required to avoid serious injury.Medical intervention in this surgery was removal of the loose metal debris via forceps and irrigtion from the incision site.The two damaged set screws show that one thread was engaged on one side of the pedicle screw tulip.The sheared thread indicates a high force being applied from the rod during final tightening.The rod was not fully reduced as indicated by the top thread of the set screw being intact.The rod reducer improved the situation when used after the two set screws were damaged.This allowed the third set screw and second pedicle screw to successfully final tighten.The pedicle screw that was removed is intact with scratches on the threads from the sheared set screw.The 9.5n-m torque handle is within specifications.

Event Description

The event took place during a 2 level pedicle screw construct l3-l5 using midline technique.Two set screw threads sheared during final torque step on the same pedicle screw.L5 screw was where the issue occured.All set screws were placed; the order of final tightenting is unknown.The first failed set screw was removed and replaced with a second set screw.After the second set screw failed, both the pedicle screw and set screw were removed and replaced.The rod reducer was used prior to final tightening the third set screw.The third set screw and second pedicle screw were successful.Sheared material from the set screws were removed with forceps and irrigated with antibiotics.No patient harm and the surgery was completed as intended.Set screw, pedicle screw and torque handle were returned for evaluation.01-80325, (b)(6) set screw (qty 2).01-80169-45r, ie18 pedicle screw.11-80032, eh21 9.5n-m torque handle.

• Brand Name: PEDFUSE
• Type of Device: PEDICLE SCREW SYSTEM
• Manufacturer (Section D): LESSPINE INNOVATIONS; 350 main st; malden 02148
• Manufacturer (Section G): LESSPINE INNOVATIONS; 350 main st; malden 02148
• Manufacturer Contact: vito lore ; 350 main st; malden 02148 ; 9782323990
• MDR Report Key: 17852446
• MDR Text Key: 324706627
• Report Number: 3005977257-2023-00009
• Device Sequence Number: 1
• Product Code: MNI
• UDI-Device Identifier: 00190361028185
• UDI-Public: (01)00190361028185(10)EJ24
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 01-80325
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Required Intervention