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

Model Number	P12.5-80B275
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	11/13/2024
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 indicating that the patient underwent bilateral femur lengthening on (b)(6) 2024.Subsequently, the patient reported experiencing a ¿popping¿ sensation in the right femur during routine physical therapy.While the exact date of occurrence is unclear, it is estimated to have taken place within 7 to 10 days prior to (b)(6) 2024.Upon further evaluation using radiographic imaging, a fracture of the femoral nail was identified.The patient denied any history of torsional forces or exceeding prescribed weight-bearing limitations.The reported ¿popping¿ was accompanied by pain and rotational instability.On (b)(6) 2024, the fractured nail was successfully replaced, and the patient is now set to resume post-operative lengthening.

• Brand Name: PRECICE SYSTEM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED; 2560 general armistead avenue; audubon PA 19403
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED; 2560 general armistead avenue; audubon PA 19403
• Manufacturer Contact: whitney ginter ; 2560 general armistead avenue; audubon, PA 19403 ; 8582005905
• MDR Report Key: 20833101
• Report Number: 3006179046-2024-00185
• Device Sequence Number: 3864693
• Product Code: HSB
• UDI-Device Identifier: 00812258020330
• UDI-Public: 812258020330
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K220234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: P12.5-80B275
• Device Lot Number: 4020901
• 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: 11/14/2024
• Initial Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/09/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown