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

Catalog Number UNK_SPE

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Date 05/13/2023

Event Type  Injury  

Manufacturer Narrative

H3 other text : device location unknown.

Event Description

The article 'risk factors for distal construct failure in posterior spinal instrumented fusion for adolescent idiopathic scoliosis: a retrospective cohort study' in spine deformity, volume 11 (1169-1176) 2023, was reviewed.Two hundred and fifty-six patients were included in this retrospective cohort study.Twenty-eight of the patients required at least one reoperation; six patients required more than one reoperation.Of the thirty-five reoperations, nine cases were attributed to distal construct failure (dcf).Of those nine cases, two patients are awaiting revision whilst one patient was managed nonoperatively.It was reported that patients were implanted with either mesa devices or devices of non-stryker manufacture.Additional information has been requested of the corresponding author and, upon receipt of such information, this report will be updated.This report captures one patient who experienced a fractured, distal screw in an 8-level construct and is waitlisted for revision surgery.

Event Description

The article 'risk factors for distal construct failure in posterior spinal instrumented fusion for adolescent idiopathic scoliosis: a retrospective cohort study' in spine deformity, volume 11 (1169-1176) 2023, was reviewed.Two hundred and fifty-six patients were included in this retrospective cohort study.Twenty-eight of the patients required at least one reoperation; six patients required more than one reoperation.Of the thirty-five reoperations, nine cases were attributed to distal construct failure (dcf).Of those nine cases, two patients are awaiting revision whilst one patient was managed nonoperatively.It was reported that patients were implanted with either mesa devices or devices of non-stryker manufacture.Additional information has been requested of the corresponding author and, upon receipt of such information, this report will be updated.This report captures one patient who experienced a fractured, distal screw in an 8-level construct and is waitlisted for revision surgery.

Manufacturer Narrative

H6 coding has been updated to reflect completion of the investigation.

• Brand Name: UNKNOWN_K2M_PRODUCT
• Type of Device: 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: 18016468
• MDR Text Key: 326676429
• Report Number: 3004774118-2023-00139
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SPE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2023
• 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 Age: 15 YR
• Patient Sex: Female