MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE RELINE MAS SYSTEM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number D10000497

Device Problem Separation Failure (2547)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/20/2023

Event Type  malfunction  

Manufacturer Narrative

The reported event was unable to be confirmed due to limited information received concerning this event.Photographs of the instrument were provided; however, without the ability to examine the device or view the condition of the plunger component, no analysis could be performed using the images.No device was returned to nuvasive for evaluation; further, operative notes were not provided for review of usage/technique.A review of the device history record was performed and no discrepancies relevant to the reported event were found.A definitive root cause was unable to be determined with the information provided.Labeling review: "¿warnings, cautions and precautions: the implantation of spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient." ".Pre-operative warnings: care should be used in the handling and storage of the reline implants.The implants should not be scratched or damaged.Implants and instruments should be protected during storage and from corrosive environments.Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." ".Packaging: packages for each of the components should be intact upon receipt.Devices should be carefully examined for completeness, and for lack of damage, prior to use.Damaged packages or products should not be used, and should be returned to nuvasive.Reusable instruments should be reprocessed using instructions provided below." if any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

Event Description

It was reported that during a procedure, the inserter's rod engagement feature was not functioning appropriately, which prevented the fixation rod from easily disengaging from the inserter.There was no reported adverse impact to the patient, user, or procedure.No additional information is available.

• Brand Name: NUVASIVE RELINE MAS SYSTEM
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INC.; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 18591989
• MDR Text Key: 334372966
• Report Number: 2031966-2024-00037
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00887517511041
• UDI-Public: 887517511041
• Combination Product (y/n): N
• Reporter Country Code: LO
• PMA/PMN Number: EXEMPT
• 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: 01/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D10000497
• Device Catalogue Number: N/A
• Device Lot Number: TU7708
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNKNOWN RELINE ROD
• Patient Sex: Prefer Not To Disclose