MAUDE Adverse Event Report: K2M, INC. DEFORMITY POLYAXIAL SCREW; SIZE 6.5X75 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 3001-06575

Device Problems Fracture (1260); Material Separation (1562)

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

Event Date 09/02/2020

Event Type  Injury  

Event Description

A physician reported that a patient underwent revision surgery to replace a fractured mesa polyaxial screw.

Manufacturer Narrative

It was reported that a mesa small stature deformity polyaxial screw broke post-operatively at the sacroiliac level.The screw was returned, visually and microscopically inspected.Upon review of the part, it was observed that the screw head assembly was separated from the screw shank.The proximal ball feature of the screw shank exhibited deformations suggesting that the screw was positioned at an angle.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.A review of complaint history associated with the subject catalog number was performed and no adverse trends were observed.The tulip disengagement was also confirmed via x-ray.It is possible that non-union contributed to the failure.According to the company representative in the field, it could not be determined if fusion was achieved.Non-union could allow for continued dynamic motion within the construct, which may contribute to a failure of this nature.Post-operative patient activity may have also contributed to the failure.

Event Description

A physician reported that a patient underwent revision surgery to replace a fractured mesa polyaxial screw.

• Brand Name: DEFORMITY POLYAXIAL SCREW; SIZE 6.5X75 MM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10616912
• MDR Text Key: 209648673
• Report Number: 3004774118-2020-00222
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10888857047020
• UDI-Public: 10888857047020
• 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: 02/23/2021

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 Model Number: 3001-06575
• Device Catalogue Number: 3001-06575
• Device Lot Number: BMBB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2020
• Initial Date Manufacturer Received: 09/02/2020
• Initial Date FDA Received: 10/01/2020
• Supplement Dates Manufacturer Received: 01/26/2021
• Supplement Dates FDA Received: 02/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention