MAUDE Adverse Event Report: K2M, INC. DEFORMITY, UNIPLANAR SCREW; SIZE 6.5X45 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 801-36545M

Device Problem Migration (4003)

Patient Problem Nerve Damage (1979)

Event Date 10/08/2020

Event Type  Injury  

Event Description

It was reported that a rod slipped out of the head of a mesa deformity uniplanar screw one year post-operatively.Due to the failure, the "exiting nerve root" was compressed.Revision surgery has been performed and the screw has been replaced.

Manufacturer Narrative

Updated d9 as product was returned on 12/10/2020.

Event Description

It was reported that a rod slipped out of the head of a mesa deformity uniplanar screw one year post-operatively.Due to the failure, the "exiting nerve root" was compressed.Revision surgery has been performed and the screw has been replaced.

Manufacturer Narrative

D.4.Lot number has been updated from 'hmhr' to 'hnhr'.Visual inspection: the device was inspected, and it was observed that the screw was positioned in the locked state; however, the inner collet was not completely flush with the outer collet.Analysis of the provided radiological images confirmed that rod slippage had occurred at the distal end of the construct.Functional inspection: some resistance was experienced during locking/unlocking.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.Per mesa surgical technique: these internal fixation devices are load sharing devices which maintain alignment until healing occurs.If healing is delayed or does not occur, the implant could eventually break, bend, or loosen.Incidence of pseudoarthrosis could allow for continued dynamic motion within the construct, leading to the axial slip along the rod.Upon review of the part, it was observed that the screw was positioned in the locked state; however, the inner collet was not completely flush with the outer collet.Analysis of the provided radiological images confirmed that rod slippage had occurred at the distal end of the construct.It is possible that non-union contributed to the failure.

Event Description

It was reported that a rod slipped out of the head of a mesa deformity uniplanar screw one year post-operatively.Due to the failure, the "exiting nerve root" was compressed.Revision surgery has been performed and the screw has been replaced.

• Brand Name: DEFORMITY, UNIPLANAR SCREW; SIZE 6.5X45 MM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10824971
• MDR Text Key: 215906133
• Report Number: 3004774118-2020-00302
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10888857140301
• UDI-Public: 10888857140301
• 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,Followup
• Report Date: 02/04/2021

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: 801-36545M
• Device Catalogue Number: 801-36545M
• Device Lot Number: HNHR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Initial Date Manufacturer Received: 10/28/2020
• Initial Date FDA Received: 11/11/2020
• Supplement Dates Manufacturer Received: 12/08/2020; 01/14/2021
• Supplement Dates FDA Received: 12/29/2020; 02/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR