MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED PRECICE SYSTEM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	P10.7-80E245
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Metal Related Pathology (4530)
Date of Event	09/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned for evaluation.The root cause is unable to be determined at this time.If any additional information is provided, a supplemental report will be submitted.
Event or Problem Description
Information was received that the patient is undergoing stature lengthening with retrograde nails.It was noticed that the crown of both nails were disengaged which would allow for free rotation of the nail.At this time it is unknown if a revision procedure has been performed.Complaint 2 of 2.
Event or Problem Description
Additional information was received that a revision procedure was performed and the crown component of the nail had to be removed in several pieces.After removal, there also appeared to be evidence of metallic debris in the surrounding soft tissue.The revision surgery was completed with no issue or adverse consequences to the patient.
Additional Manufacturer Narrative
The device has not been returned for evaluation, and no soft tissue samples or radiographic images have been provided.Consequently, the root cause cannot be determined at this time.Should any additional information become available, a supplemental report will be issued.

• Brand Name: PRECICE SYSTEM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED; 101 enterprise suite 100; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED; 101 enterprise suite 100; aliso viejo CA 92656
• Manufacturer Contact: whitney ginter ; 101 enterprise suite 100; aliso viejo, CA 92656 ; 8582005905
• MDR Report Key: 20362299
• Report Number: 3006179046-2024-00177
• Device Sequence Number: 21230583
• Product Code: HSB
• UDI-Device Identifier: 00812258020828
• UDI-Public: 812258020828
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K220234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: P10.7-80E245
• Device Lot Number: 3120807AAA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2024
• Supplement Date Received by Manufacturer: 10/07/2024
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/08/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown