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

Model Number	801-35535
Health Effect - Clinical Code	Neurological Deficit/Dysfunction (1982)
Date of Event	05/05/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device remains implanted in patient.
Event or Problem 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 or Problem 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.
Additional Manufacturer Narrative
Corrected data: changed outcomes attributed to adverse event from no selection to required intervention to prevent permanent impairment/damage (device).
Additional 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 or Problem 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
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 9384135
• Report Number: 3004774118-2019-00153
• Device Sequence Number: 10880028
• Product Code: NKB
• UDI-Device Identifier: 10888857139824
• UDI-Public: 10888857139824
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K141873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/25/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 801-35535
• Device Catalogue Number: 801-35535
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/01/2019
• Supplement Date Received by Manufacturer: 12/09/2019; 02/28/2020
• Initial Report FDA Received Date: 11/27/2019
• Supplement Report FDA Received Date: 12/30/2019; 03/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention