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

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); No Information (3190)

Event Date 06/16/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not received by nuvasive as it is still in-situ.No radiographic images have been provided.The patients bone quality is unknown.It is unknown if fusion has occurred.No root cause can be identified at this time.Labeling review: ".Preoperative warning: care should be used in the handling and storage of the implants.The implants should not be scratched or damaged.Implants and instruments should be protected during storage and from corrosive environments." ".All non-sterile parts should be cleaned and sterilized before use.Devices should be inspected for damage prior to implantation.Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." ".Potential adverse events and complications: potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s), loss of fixation, nonunion or delayed union.".

Event Description

On (b)(6) 2019, patient underwent a posterior lumbar interbody fusion procedure at the l3 to s1 levels where posterior fixation was used.As per the report it was discovered that a screw at the s1 level had become loose.A revision is planed to be performed in the near future but the details could not been be obtained at this time.

• Brand Name: NUVASIVE RELINE SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE INC.; 7475 lusk blvd; san diego 92121
• Manufacturer (Section G): NUVASIVE INC.; 7475 lusk blvd; san diego 92121
• Manufacturer Contact: dean lucas ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 10261792
• MDR Text Key: 199992212
• Report Number: 2031966-2020-00144
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K143684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention