MAUDE Adverse Event Report: NUVASIVE INCORPORATED NUVASIVE RELINE SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	13066540
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Nerve Damage (1979)
Date of Event	02/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product malfunction has been alleged.Though no malfunction was suggested an examination of the ex-planted device found no defects or malfunctions related to the reported event and found to meet all design specifications.No radiographs or images were provided so the breech could not be confirmed.Review of the reported event indicates a procedural error related to either an over sized implant selection or improper angulation during implantation may have contribute to alleged event.Labeling review: ".Ensure the k-wire is not advancing as the path is created over the k-wire.Use lateral fluoroscopy to properly manage the k-wire during pedicle preparation to confirm proper placement and avoid anterior advancement of the k-wire." ".K-wire should be removed when screw has reached the posterior wall of the pedicle to avoid kink in tip." ".Correct selection of the implant is extremely important.The potential for success is increased by the selection of the proper size of the implant.While proper selection can minimize risks, the size and shape of human bones present limitations on the size and strength of implants.".
Event or Problem Description
A patient underwent a posterior fixation procedure on (b)(6) 2020 at l4-5, levels.As per reporter the pedicle of left l5 level was breached by the tip of pedicle screw while the physician was inserting the screw.There was possibility to damage a nerve.

• Brand Name: NUVASIVE RELINE SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• MDR Report Key: 9850924
• Report Number: 2031966-2020-00043
• Device Sequence Number: 2872204
• Product Code: NKB
• UDI-Device Identifier: 00887517547989
• UDI-Public: 887517547989
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K143684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/18/2020

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: 13066540
• Device Lot Number: EM6784
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2020
• Initial Report FDA Received Date: 03/18/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention