MAUDE Adverse Event Report: K2M, INC. UNKNOWN_K2M_PRODUCT; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number UNK_SPE

Device Problems Microbial Contamination of Device (2303); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Injury (2348)

Event Date 08/05/2016

Event Type  Injury  

Manufacturer Narrative

Location and return status of the device is unknown.

Event Description

A physician reported revision surgery occurred to remove hardware after the patient experienced an infection.The patient had experienced wound dehiscence approximately one year previous.The wound dehiscence resolved without treatment.

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.Per surgical technique: potential adverse events: potential adverse events associated with spinal fusion procedures include, but are not limited to pseudoarthrosis; loosening, bending, cracking or fracture of components, or loss of fixation in the bone with possible neurologic damage, usually attributable to pseudoarthrosis, insufficient bone stock, excessive activity or lifting, or one or more of the factors listed in contraindications, or warnings and precautions; infections possibly requiring removal of devices; palpable components, painful bursa, and/or pressure necrosis; and allergies, and other reactions to device materials which, although infrequent, should be considered, tested for (if applicable), and ruled out preoperatively.Potential risks also include those associated with any spinal surgery resulting in neurological, cardiovascular, respiratory, gastrointestinal or reproductive compromise, or death.Wound dehiscence and/or infection can occur post-operatively and are likely attributed to the procedure rather than a malfunction of the mesa rail device.

Event Description

A physician reported revision surgery occurred to remove mesa hardware after the patient experienced an infection.The patient had experienced wound dehiscence approximately one year previous.The wound dehiscence resolved without treatment.

• Brand Name: UNKNOWN_K2M_PRODUCT
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 9254706
• MDR Text Key: 164261345
• Report Number: 3004774118-2019-00132
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 08/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SPE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention