MAUDE Adverse Event Report: K2M, INC. LAMINAR HOOK; SIZE 10 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	801-81002H
Medical Device Problem Codes	Unintended Movement (3026); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Spinal Cord Injury (2432)
Date of Event	05/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A company representative reported that, during a scoliosis correction, a mesa laminar hook entered the patient's spinal canal.Neuromonitoring was temporarily lost and the patient was woken up mid-surgery to test foot mobility.All of the implants were removed and the patient was reported to be mobile after the surgery.
Event or Problem Description
A company representative reported that, during a scoliosis correction, a mesa laminar hook entered the patient's spinal canal.Neuromonitoring was temporarily lost and the patient was woken up mid-surgery to test foot mobility.All of the implants were removed and the patient was reported to be mobile after the surgery.
Additional Manufacturer Narrative
H6 coding has been updated to reflect investigation conclusion.

• Brand Name: LAMINAR HOOK; SIZE 10 MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer (Section G): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 19371212
• Report Number: 3004774118-2024-00026
• Device Sequence Number: 12667119
• Product Code: NKB
• UDI-Device Identifier: 10888857142879
• UDI-Public: 10888857142879
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K140765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 801-81002H
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/08/2024
• Supplement Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 17 YR
• Patient Sex: Unknown