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

Model Number 10000751

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/15/2022

Event Type  malfunction  

Manufacturer Narrative

The device was received by nuvasive japan and photographs and radiographs provided confirmed the complaint.No torque information provided and it is unknown if the surgeon utilized hand tightening.Review of the provided photographs reveal were unable to determine the fracture pattern so a definitive root cause cannot be determined though excessive off angled torque and or aged wear fatigue may be related cause or contributor.No additional investigation can be completed.Labeling review: ".Potential adverse events and complications: as with any major surgical procedures, there are risks involved in orthopedic surgery.Potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant components." ".Warnings, cautions and precautions: all lock screws should be final-tightened with the counter-torque and torque t-handle.Do not implant the instruments: complications to the patient may include, but are not limited to: nerve damage, paralysis, pain, or damage to soft tissue, visceral organ, or joints.Dural leak in cases of excessive load application or impingement of close vessels, nerves, and/or organs by slippage or misplacement of the instrument.Bony fracture, especially in the case of deformed spine or weak bone.Infection, if instruments are not properly cleaned and sterilized.Breakage of the device, which could make necessary removal difficult or sometimes impossible, with possible consequences of late infection and migration.Breakage could cause injury to the patient.Pain, discomfort, or abnormal sensations resulting from the presence of the device." ".Pre-operative warnings: care should be used during surgical procedures to prevent damage to the devices and injury to the patient." ".Intra-operative warnings: the physician should take precautions against putting undue stress on the spinal area with instruments.Any surgical technique should be carefully followed.It is important that the surgeon exercise extreme caution when working in close proximity to vital organs, nerves, or vessels, and that the force applied to the instrumentation is not excessive, to prevent potential injury to the patient.Over-bending, notching, striking, and/or scratching of implants with any instrument should be avoided to reduce the risk of breakage.When using the maxcess mas tlif system for distraction care must be taken to avoid damaging the pedicles which could compromise pedicle screw purchase.The physical characteristics required for many instruments do not permit them to be manufactured from implantable materials.If any broken fragments of instruments remain in the body of a patient, they could cause allergic reactions or infections.If an instrument breaks in surgery and fragments go into the patient, these pieces should be removed prior to closure and should not be implanted.".

Event Description

On (b)(6) 2022 a patient underwent a spinal procedure at l3/5.On (b)(6) 2022 radiographs revealed the driver tip was in-situ fixed in lock screw.On (b)(6) 2022 additional radiographs revealed the piece had migrated.A revision surgery will be conducted to remove the fragment.

• Brand Name: NUVASIVE RELINE SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 15204317
• MDR Text Key: 305092237
• Report Number: 2031966-2022-00141
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00887517513724
• UDI-Public: 887517513724
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K182974
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10000751
• Device Lot Number: NM4017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Male