MAUDE Adverse Event Report: NUVASIVE, INCORPORATED NUVASIVE® PRECEPT¿ SPINAL SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 10/05/2022

Event Type  Injury  

Event Description

On (b)(6) 2022 is was discovered about 10 hours post-op that bleeding was occurring and an operation took place to treat it.The amount of blood loss and the location of bleeding are unknown.The root cause of the bleeding could also not be confirmed.The patient was placed under observation and is reported to have recovered.

Manufacturer Narrative

No device was returned as no product fault was alleged.No radiographs and no description of fault, failure, or patient injury was provided.Review of the reported event identified an unknown post operative bleed was identified and treated, but due to a lack of information provided no additional investigation can be completed.Label review ".Potential adverse events and complications as with any major surgical procedures, there are risks involved in orthopedic surgery.Infrequent operative and postoperative complications that may result in the need for additional surgeries include: damage to blood vessels." ".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.".

• Brand Name: NUVASIVE® PRECEPT¿ SPINAL SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk blvd; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INCORPORATED; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 15674770
• MDR Text Key: 302435185
• Report Number: 2031966-2022-00226
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K171894
• 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: 10/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 10/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male