MAUDE Adverse Event Report: K2M, INC. 751 MILLER DRIVE SE, LEESBURG, VIRGINIA K2M SPINE SCREWS; PEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDIOPATHIC SCOLIOSIS

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 12/19/2012

Event Type  Injury  

Event Description

Empire medical; during a mast lumbar fusion the surgeon used a medtronic navlock awl and tap, and then attempted to use a different spine companies screws (k2m).The screws would not thread after attempting multiple times.Therefore, the surgeon became frustrated with the spine rep (non medtronic) and aborted navigation.A c-arm was brought in and used the other spine company's instruments to successfully finish the surgery without navigation.We all agreed that the medtronic tap was not compatible (different threads) with the spine company (k2m).(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: K2M SPINE SCREWS
• Type of Device: PEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDIOPATHIC SCOLIOSIS
• Manufacturer (Section D): K2M, INC. 751 MILLER DRIVE SE, LEESBURG, VIRGINIA
• MDR Report Key: 17536136
• MDR Text Key: 321140766
• Report Number: MW5143026
• Device Sequence Number: 1
• Product Code: OSH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/21/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1