MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INC. PRECICE® INTRAMEDULLARY LIMB LENGTHENING SYSTEM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	P10.7-80C275
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a precice nail was implanted in (b)(6) on a stature patient.His right side lengthened but the left nail did not.The patient lost faith in his original surgeon, so he came to (b)(6) to have dr.(b)(6) swap out the nail.The nail did work on the back table with a fast distractor, but (b)(6) still wanted us to swap it.
Additional Manufacturer Narrative
The investigation revealed a complaint reporting that a precice nail did not work post implantation.The nail involved in the event was received by manufacturer for investigation.The nail was removed and tested where it was able to distract.No additional information has been provided.Specified regulatory reporting has been completed.A review of device history record for the nail confirmed no deviations in the manufacturing process and that the finished product met all required quality inspections.The nail was tested according to production standards where it was able to pass all acceptance criteria, indicating that the nail is fully functioning.Complaint monitoring will continue and additional action will be taken in the event that an adverse trend is identified.No additional action is planned at this time.

• Brand Name: PRECICE® INTRAMEDULLARY LIMB LENGTHENING SYSTEM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; valley forge business center; 2560 general armistead avenue; audubon PA 19403
• Manufacturer (Section G): GLOBUS MEDICAL, INC.; valley forge business center; 2560 general armistead avenue; audubon PA 19403
• Manufacturer Contact: daniel paul ; valley forge business center; 2560 general armistead avenue; audubon, PA 19403 ; 6109301800
• MDR Report Key: 25306652
• Report Number: 3006179046-2026-00107
• Device Sequence Number: 18468263
• Product Code: HSB
• UDI-Device Identifier: 00812258020460
• UDI-Public: 812258020460
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K170169
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/27/2026

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: P10.7-80C275
• Device Lot Number: 4032603
• 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: 12/10/2025
• Initial Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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