MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE 5.5X35 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number 801-05535

Device Problems Break (1069); No Apparent Adverse Event (3189)

Patient Problems Pain (1994); Injury (2348); No Patient Involvement (2645)

Event Date 06/12/2019

Event Type  Injury  

Event Description

It was reported that the patient underwent revision surgery to remove k2m mesa system on right side, l4-l5, since the patient presented with pain.During removal, the surgeon noted a screw was broken.

Manufacturer Narrative

This has been determined to be a duplicate of manufacturer's report number 3004774118-2019-01066.

Event Description

This has been determined to be a duplicate of manufacturer's report number 3004774118-2019- 01066.

• Brand Name: POLYAXIAL SCREW; SIZE 5.5X35 MM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 8781871
• MDR Text Key: 150748325
• Report Number: 3004774118-2019-00066
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10888857135536
• UDI-Public: 10888857135536
• 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: 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 801-05535
• Device Lot Number: DJMW
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Weight: 71