MAUDE Adverse Event Report: K2M, INC. UNKNOWN MESA SCREW; POSTERIOR CERVICAL SCREW SYSTEM

Catalog Number UNK_SPE

Device Problem Migration (4003)

Patient Problems Pain (1994); Skin Tears (2516)

Event Date 10/07/2021

Event Type  Injury  

Manufacturer Narrative

Discarded by hospital.

Event Description

It was reported via (b)(6) clinical study that a patient presented with progressive pain and implant prominence and skin breakthrough approximately 3 years post-operatively.Radiographs revealed acute loosening (proximally, midpoint, and distally) and infection of the patient's metalwork.Revision surgery was performed where all the implants were removed.This report captures the third of the three mesa screws.

Manufacturer Narrative

Visual, functional, dimensional, and material analysis inspections could not be performed as the device(s) were not available.Device and complaint history records could not be reviewed as a valid lot number was not provided and could not be obtained.The patient was implanted from t3 to l2 with mesa hardware, in 2018, without complication.Clinically the patient appeared fused.In (b)(6) 2021, the patient experienced discomfort.No migrations were observed.In (b)(6) 2021, the patient presented with acute loosening and infection of metalwork.Following radiographs showed screws loosening at the proximal, midpoint, and distal levels.The patient was revised to remove the hardware.Culture samples reveal that the patient's infection was enterobacter cloacae.Consultation with hcp suggests that implant loosening and infection can be tied together, as infection compromises fusion environment, subsequently, leading to implant loosening.Some common ways of enterobacter cloacae contraction are from the gi tract, skin, and the urinary tract.From the mesa surgical technique, "potential adverse consequences include, but are not limited to pseudoarthrosis, loosening, bending, cracking or fracture of the 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 contradictions, or warnings and precautions; infections possibly requiring removal of devices." from the provided information and consultation with hcp, the likely cause of the reported screw migrations can be attributed to late infection.

Event Description

It was reported via mesa clinical study that a patient presented with progressive pain and implant prominence and skin breakthrough approximately 3 years post-operatively.Radiographs revealed acute loosening (proximally, midpoint, and distally) and infection of the patient's metalwork.Revision surgery was performed where all the implants were removed.This report captures the third of the three mesa screws.

• Brand Name: UNKNOWN MESA SCREW
• Type of Device: POSTERIOR CERVICAL 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: 12677107
• MDR Text Key: 278125652
• Report Number: 3004774118-2021-00320
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Sex: Male