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

Model Number 801-35535

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Neurological Deficit/Dysfunction (1982)

Event Date 05/05/2015

Event Type  Injury  

Manufacturer Narrative

Device remains implanted in patient.

Event Description

It was reported that a patient suffered from temporary neuro-monitoring loss following the insertion of the right side mesa uniplanar screws.The screws were replaced and re-positioned, whereas the patient regained sensory-evoked potentials.This report captures the second of three screws.

Event Description

It was reported that a patient suffered from temporary neuro-monitoring loss following the insertion of the right side mesa uniplanar screws.The screws were replaced and re-positioned, whereas the patient regained sensory- evoked potentials.This report captures the second of three screws.

Manufacturer Narrative

Corrected data: changed outcomes attributed to adverse event from no selection to required intervention to prevent permanent impairment/damage (device).

Manufacturer Narrative

Visual, dimensional, and functional analysis could not be performed as the device was not returned.A review of the device history and complaint history records could not be performed as a valid lot code was not provided and could not be obtained.Per surgical technique: the mesa surgical technique was reviewed, and the following relevant information was identified: placement of screws should be checked radiographically prior to assembly of the rod construct.Care should be taken when positioning the implants to avoid neurological damage.It was speculated in event op notes that there may have been a small lateral breach at the t11 and t10 level on the right side which may have contributed to the asymmetry in neurological monitoring.It is also possible that the screws may have been implanted in a compromising trajectory which may have contributed to the event.

Event Description

It was reported that a patient suffered from temporary neuro-monitoring loss following the insertion of the right side mesa uniplanar screws.The screws were replaced and re-positioned, whereas the patient regained sensory-evoked potentials.This report captures the second of three screws.

• Brand Name: UNIPLANAR 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: 9384135
• MDR Text Key: 168451662
• Report Number: 3004774118-2019-00153
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10888857139824
• UDI-Public: 10888857139824
• Combination Product (y/n): N
• PMA/PMN Number: K141873
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Type of Report: Initial,Followup,Followup
• Report Date: 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 801-35535
• Device Catalogue Number: 801-35535
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention