MAUDE Adverse Event Report: K2M, INC. UNKNOWN MESA SCREW; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number UNK_SPE

Device Problems Insufficient Information (3190); Migration (4003)

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

Event Date 05/25/2021

Event Type  Injury  

Manufacturer Narrative

Return status of device is unknown.

Event Description

It was reported that a patient underwent revision surgery to replace an unspecified mesa screw which did not retain a rod, leading to rod migration.

Event Description

It was reported that a patient underwent revision surgery to replace an unspecified mesa screw which did not retain a rod, leading to rod migration.

Manufacturer Narrative

Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device and complaint history records review could not be performed as a valid lot code was not provided and could not be obtained.It was reported that no further information regarding the event will be provided due to hospital policy.Due to lack of information and device not returned, an exact cause cannot be determined.Potential causes include inadequate construct and patient factors including post op activity level.

• Brand Name: UNKNOWN MESA SCREW
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 11966817
• MDR Text Key: 255132248
• Report Number: 3004774118-2021-00170
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K141873
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/25/2021

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SPE
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/25/2021
• Initial Date FDA Received: 06/09/2021
• Supplement Dates Manufacturer Received: 09/27/2021
• Supplement Dates FDA Received: 10/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention