MAUDE Adverse Event Report: K2M, INC. DEFORMITY, UNIPLANAR SCREW; SIZE 7.5X45 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 801-37545M

Device Problem Mechanical Problem (1384)

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

Event Date 10/15/2020

Event Type  malfunction  

Event Description

It was reported that after final locking, the rod was still able to slide in the head of the mesa deformity uniplanar screw.Surgery was successfully completed with another screw, and an unknown delay.No adverse consequences, or medical intervention were reported.

Manufacturer Narrative

Visual inspection: the returned screw had loss of anodization and slight deformation around the inner and outer collet which did not impact the functionality of the device.Functional inspection: the complaint screw was functionally inspected using the returned denali rod as well as a sample rod.The device was able to final lock onto the rods, using a sample quick locker, without issue.The rods were not able to slide along the collets, as reported.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.It is possible that the screw was not in a completely locked state during the procedure, causing the rod to slip along the screw head.As certain maneuvers applied during the procedure could not be replicated during functional testing, the failure mode could not be confirmed and the root cause could not be determined conclusively.

Event Description

It was reported that after final locking, the rod was still able to slide in the head of the mesa deformity uniplanar screw.Surgery was successfully completed with another screw and an unknown delay.No adverse consequences or medical intervention were reported.

• Brand Name: DEFORMITY, UNIPLANAR SCREW; SIZE 7.5X45 MM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10824423
• MDR Text Key: 216628159
• Report Number: 3004774118-2020-00300
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10888857140660
• UDI-Public: 10888857140660
• Combination Product (y/n): N
• PMA/PMN Number: K141873
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 801-37545M
• Device Catalogue Number: 801-37545M
• Device Lot Number: GXXF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2020
• Date Manufacturer Received: 01/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1